Hypertension, Pulmonary
Conditions
Keywords
Ambrisentan, Bioavailability, Tadalafil, Fixed Dose combination
Brief summary
This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram \[mg\] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
Interventions
DRUGFDC (ambrisentan 10 mg-tadalafil 40 mg) single dose
The four FDCs in part 1 will have the following formulation designation: FDC1, FDC2, FDC3 and FDC4. They are film-coated tablets. The dose will be administered orally. Study treatment for Part2 and Part 3 will be amended after Part 1 study
DRUGReference (ambrisentan 10 mg + tadalafil 40 mg given concurrently)
Ambrisentan is a film-coated tablet. Each tablet of ambrisentan contains 10 mg of ambrisentan, approximately 95 mg of lactose (as monohydrate), 0.25 mg of lecithin and 0.11 mg of Allura red AC Aluminium Lake. Tadalafil is also a film-coated tablet. Each tablet of Tadalafil contains 20 mg tadalafil and 233 mg lactose. Both the tablets will be administered orally concurrently.
Sponsors
Covance Harrogate
Hammersmith Medicines Research
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 60 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring (ECG and 24 hour Holter). A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the Investigator, in consultation with Medical Monitor if required, judges and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight \>= 50 Kilogram (kg) (110 pounds \[lbs\]) for men and \>= 45 kg (99lbs) for women and body mass index (BMI) within the range 18 - 30 kg per square metre (m\^2) (inclusive) * Male or Female. Female with non-reproductive potential defined as, Pre-menopausal females with one of the following: Documented tubal ligation or Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or Hysterectomy or Documented Bilateral Oophorectomy, Documented Postmenopausal defined as 12 months of spontaneous amenorrhea * Capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data. |
| Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples were collected at the indicated time-points. The analysis was done under fasting condition post single dose. There is no formal hypothesis tested for Part 1 of the study. |
| AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples at Part 1, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. The PK Parameter Population was used for analysis. There is no formal hypotheses tested for Part 1 of the study. |
| Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time-points, of Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting condition post single dose. PK parameter Populatio was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. PK parameter Population was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used. |
| AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48 and 72 hours post-dose. The analysis, was done under fed and fasting conditions post single dose. PK parameter population was used. |
| AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used. |
| Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. |
| AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36,48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK Parameter Population was used for analysis. |
| AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis. |
| Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used. |
| AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting conditions post single dose. PK parameter population was used for analysis. |
| AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Vital- Temperature, Part 2 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product. |
| Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital- SBP and DBP, Part 3A | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP, DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital Signs-Heart Rate, Part 3A | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital- Temperature, Part 3A | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital- SBP and DBP, Part 3B | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital Signs-Heart Rate, Part 3B | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for HR. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital- Temperature, Part 3B | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | Up to Day 3 | 12-lead ECG, was measured in semi-supine position after 5 minutes rest. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. |
| Number of Participants With Abnormal ECG Findings, -Part 2 | Up to Day 3 | 12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. |
| Number of Participants With Abnormal ECG Findings, -Part 3A | Up to Day 3 | 12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. |
| Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Up to Day 2 | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis. |
| Number of Participants With Abnormal ECG Findings, -Part 3B | Up to Day 3 | 12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. |
| Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Up to Day 3 | Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Number of Participants With Hematology Values of PCI - Part 2 | Day 2 | Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Number of Participants With Hematology Values of PCI - Part 3A | Day 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hours). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Number of Participants With Hematology Values of PCI - Part 3B | Day 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Number of Participants With Clinical Chemistry Values of PCI- Part1 | Day 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Day 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. |
| Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Up to Day 2 | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis |
| Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Up to Day 2 | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis. |
| Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Up to Day 2 | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis. |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Up to 42 days | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. |
| Number of Participants With SAEs and AEs-Part 2 | Up to 35 days | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. |
| Number of Participants With SAEs and AEs-Part 3A | Up to 44 days | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. |
| Number of Participants With SAEs and AEs-Part 3B | Up to 44 days | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. |
| Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Day 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. |
| Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | Serial blood samples were collected at the indicated time-points. In Part 3B, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. |
| Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. |
| Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints. |
| Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48, and 72 hours postdose | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints. |
| Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product. |
| Change From Baseline in Vital Signs-Heart Rate, Part 1 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital- Temperature, Part 1 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Change From Baseline in Vital- SBP and DBP, Part 2 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. |
| Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Day 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. |
| Change From Baseline in Vital Signs-Heart Rate, Part 2 | Baseline and Up to Day 3 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a single dose, randomized, open-label, crossover study in healthy participants. A total of 112 healthy participants were randomized and received the study treatment. The study was conducted at a single center in the United Kingdom.
Pre-assignment details
A total of 174 participants were screened, of which 59 were screen failures and 3 participants were reserve participants. Thus 112 participants were randomized. The study, was conducted in three parts: Part 1 (5 way crossover) and Parts 2 and 3 (A and B), followed 4 way crossover design.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 In Part 1, there were 5 dosing sessions of four formulations of the FDCs (ambrisentan 10 mg + tadalafil 40 mg) (F1, F2, F3, F4) and 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg (R) which were administered concurrently . The participants received a single oral dose of formulation or the reference during each session. All the doses were taken in fasted condition. The treatment period for Part 1 was of 4-weeks, post which there was a follow-up period of 14 days (which included 7-days washout) | 26 |
| Part 2 This comprised of 4 dose sessions, of 3 different granulation sizes for a single FDC (ambrisentan 10 mg +tadalafil 40 mg) compared to the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg & tadalafil 40 mg), to evaluate the bioavailability. This part of the study provided data for 3 granulation size forms of a single FDC formulation selected from Part 1. The participants received a single oral dose during each session. All the doses were taken in fasted condition. The treatment period for Part 2 was of 4-weeks, post which a follow-up period of 14 days (which included 7-days washout). Part 2 had FG1, FG2, FG3 which are Ambrisentan and Tadalafil FDCs (10mg/40mg). R is ambrisentan and tadalafil monotherapies taken concurrently (10mg/40mg). | 21 |
| Part 3A This comprised of 4 dose sessions of the FDC against the reference ambrisentan 10 mg + tadalafil 40mg monotherapies in the fed and fasted state, taken to evaluate the bioequivalence. The participants received a single oral dose during each session, taken under fed and fasted conditions. The fed arms of this part of the study received a standard high fat breakfast. The treatment period of Part 3A was of 4-weeks, post which a follow-up period of 14 days (which included 10-days washout). In Part 3A, X1, X2 are ambrisentan and tadalafil FDCs (10mg/40mg),where X1 is under fed state and X2 is under fasted state. R1, R2 are Ambrisentan and Tadalafil monotherapies taken concurrently(10mg/40mg), where R1 is under fed state and R2 is under fasted state. | 33 |
| Part 3B This study part comprised of 4 dose sessions which assessed the bioequivalence of the two FDC dose strengths, (ambrisentan 5 mg + tadalafil 40mg and ambrisentan 5 mg + tadalafil 20mg) against the reference ambrisentan 5 mg + tadalafil 40mg monotherapies and ambrisentan 5 mg + tadalafil 20mg monotherapies in the fasted state. The treatment period of Part 3B was of 4-weeks, post which there was a follow-up period of 14 days (which included 10-days washout). In the Part 3B, Y1, Y2 are ambrisentan and tadalafil FDCs, under fasted state, where Y1 is 5mg/40mg and Y2 is 5mg/20mg and R3, R4 are ambrisentan and tadalafil monotherapies taken concurrently, under fasted state, where R3 is 5mg/40mg and R4 is 5mg/20mg. | 32 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1, Period 1 (up to 6 Days) | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1, Period 1 (up to 6 Days) | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1, Period 2 (up to 6 Days) | Protocol defined stop criteria reached | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1, Washout Period 1 (7 Days) | Protocol defined stop criteria reached | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1, Washout Period 3 (7 Days) | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2, Period 1 (up to 6 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 3A, Period 1 (up to 6 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 3B, Period 3 (up to 6 Days) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part 3B, Washout Period 3 (10 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Part 3B, Washout Period 3 (10 Days) | Study terminated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 2 | Part 3A | Part 3B | Total | Part 1 |
|---|---|---|---|---|---|
| Age, Continuous | 36.8 Years STANDARD_DEVIATION 12.07 | 37.3 Years STANDARD_DEVIATION 10.36 | 30.9 Years STANDARD_DEVIATION 12.05 | 35.5 Years STANDARD_DEVIATION 11.71 | 37.7 Years STANDARD_DEVIATION 11.68 |
| Race/Ethnicity, Customized Race, Customized Asian-Central/South Asian Heritage | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race, Customized Asian- South East Asian heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race, Customized Black Or African American | 1 Participants | 5 Participants | 8 Participants | 17 Participants | 3 Participants |
| Race/Ethnicity, Customized Race, Customized Multiple-Asian and White | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race, Customized White - Arabic/North African Heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race, Customized White/Caucasian/European Heritage | 20 Participants | 25 Participants | 22 Participants | 90 Participants | 23 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 33 Participants | 31 Participants | 111 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 23 | 0 / 23 | 0 / 22 | 0 / 21 | 0 / 21 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 32 | 0 / 33 | 0 / 32 | 0 / 32 | 0 / 30 | 0 / 31 | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 10 / 21 | 12 / 23 | 13 / 23 | 14 / 22 | 12 / 21 | 13 / 21 | 12 / 20 | 14 / 20 | 12 / 20 | 22 / 32 | 21 / 33 | 24 / 32 | 22 / 32 | 19 / 30 | 17 / 31 | 22 / 32 | 13 / 30 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 | 0 / 23 | 0 / 22 | 0 / 21 | 0 / 21 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 32 | 0 / 33 | 0 / 32 | 0 / 32 | 0 / 30 | 0 / 31 | 0 / 32 | 0 / 30 |
Outcome results
Primary
Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples were collected at the indicated time-points. The analysis was done under fasting condition post single dose. There is no formal hypothesis tested for Part 1 of the study.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, (AUC 0 - inf) | 5566.06 Hour*nanogram per milliliter | Geometric Coefficient of Variation 23.8 |
| Part 1,Treatment F1 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, (AUC 0 - inf) | 13408.30 Hour*nanogram per milliliter | Geometric Coefficient of Variation 41.3 |
| Part 1,Treatment F2 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, (AUC 0 - inf) | 5556.44 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.9 |
| Part 1,Treatment F2 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, (AUC 0 - inf) | 14415.47 Hour*nanogram per milliliter | Geometric Coefficient of Variation 41.8 |
| Part 1,Treatment F3 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, (AUC 0 - inf) | 5788.91 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.8 |
| Part 1,Treatment F3 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, (AUC 0 - inf) | 14545.28 Hour*nanogram per milliliter | Geometric Coefficient of Variation 38.4 |
| Part 1,Treatment F4 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, (AUC 0 - inf) | 14418.35 Hour*nanogram per milliliter | Geometric Coefficient of Variation 37.8 |
| Part 1,Treatment F4 | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, (AUC 0 - inf) | 6007.57 Hour*nanogram per milliliter | Geometric Coefficient of Variation 23.7 |
| Part 1, Treatment R | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, (AUC 0 - inf) | 5746.73 Hour*nanogram per milliliter | Geometric Coefficient of Variation 20.8 |
| Part 1, Treatment R | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, (AUC 0 - inf) | 13955.85 Hour*nanogram per milliliter | Geometric Coefficient of Variation 36.2 |
Primary
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting conditions post single dose. PK parameter population was used for analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Ambrisentan AUC (0-inf) | 3347.76 Hour*nanogram per milliliter | Geometric Coefficient of Variation 20.9 |
| Part 1,Treatment F1 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Tadalafil, AUC (0-inf) | 7962.14 Hour*nanogram per milliliter | Geometric Coefficient of Variation 32.2 |
| Part 1,Treatment F2 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Ambrisentan AUC (0-inf) | 3205.51 Hour*nanogram per milliliter | Geometric Coefficient of Variation 20.6 |
| Part 1,Treatment F2 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Tadalafil, AUC (0-inf) | 7748.47 Hour*nanogram per milliliter | Geometric Coefficient of Variation 32.6 |
90% CI: [1.0009, 1.071]
90% CI: [0.991, 1.0834]
Primary
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36,48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK Parameter Population was used for analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Ambrisentan AUC (0-inf) | 3397.51 Hour nanogram per milliliter | Geometric Coefficient of Variation 19.7 |
| Part 1,Treatment F1 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Tadalafil, AUC (0-inf) | 14724.34 Hour nanogram per milliliter | Geometric Coefficient of Variation 39.7 |
| Part 1,Treatment F2 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Ambrisentan AUC (0-inf) | 3277.81 Hour nanogram per milliliter | Geometric Coefficient of Variation 20.8 |
| Part 1,Treatment F2 | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Tadalafil, AUC (0-inf) | 14938.29 Hour nanogram per milliliter | Geometric Coefficient of Variation 40.7 |
90% CI: [1.0168, 1.0617]
90% CI: [0.9106, 1.056]
Primary
AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48 and 72 hours post-dose. The analysis, was done under fed and fasting conditions post single dose. PK parameter population was used.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Ambrisentan, AUC (0-inf) | 6075.51 Hour*nanogram per milliliter | Geometric Coefficient of Variation 26.1 |
| Part 1,Treatment F1 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Tadalafil, AUC (0-inf) | 16086.66 Hour*nanogram per milliliter | Geometric Coefficient of Variation 41.5 |
| Part 1,Treatment F2 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Tadalafil, AUC (0-inf) | 14856.32 Hour*nanogram per milliliter | Geometric Coefficient of Variation 40 |
| Part 1,Treatment F2 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Ambrisentan, AUC (0-inf) | 6231.48 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.1 |
| Part 1,Treatment F3 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Ambrisentan, AUC (0-inf) | 5898.72 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.7 |
| Part 1,Treatment F3 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Tadalafil, AUC (0-inf) | 16596.18 Hour*nanogram per milliliter | Geometric Coefficient of Variation 37.8 |
| Part 1,Treatment F4 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Ambrisentan, AUC (0-inf) | 6155.60 Hour*nanogram per milliliter | Geometric Coefficient of Variation 24.4 |
| Part 1,Treatment F4 | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | Tadalafil, AUC (0-inf) | 14612.84 Hour*nanogram per milliliter | Geometric Coefficient of Variation 41.5 |
90% CI: [0.9965, 1.0646]
90% CI: [0.982, 1.0473]
90% CI: [0.931, 1.0092]
90% CI: [0.9553, 1.0799]
Primary
AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting condition post single dose. PK parameter Populatio was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, AUC (0-inf) (n=21,20,20,20) | 6029.19 Hour*nanogram per milliliter | Geometric Coefficient of Variation 29.6 |
| Part 1,Treatment F1 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, AUC ( 0 - inf) (n=20,20,20,20) | 14006.59 Hour*nanogram per milliliter | Geometric Coefficient of Variation 46.7 |
| Part 1,Treatment F2 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, AUC ( 0 - inf) (n=20,20,20,20) | 14443.86 Hour*nanogram per milliliter | Geometric Coefficient of Variation 44.8 |
| Part 1,Treatment F2 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, AUC (0-inf) (n=21,20,20,20) | 6179.41 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.2 |
| Part 1,Treatment F3 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, AUC (0-inf) (n=21,20,20,20) | 6189.22 Hour*nanogram per milliliter | Geometric Coefficient of Variation 29.5 |
| Part 1,Treatment F3 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, AUC ( 0 - inf) (n=20,20,20,20) | 14502.37 Hour*nanogram per milliliter | Geometric Coefficient of Variation 40.5 |
| Part 1,Treatment F4 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, AUC (0-inf) (n=21,20,20,20) | 6201.40 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.7 |
| Part 1,Treatment F4 | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, AUC ( 0 - inf) (n=20,20,20,20) | 14457.33 Hour*nanogram per milliliter | Geometric Coefficient of Variation 40.5 |
Primary
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B | Ambrisentan AUC (0-t) | 3254.70 Hour*nanogram per milliliter | Geometric Coefficient of Variation 21 |
| Part 1,Treatment F1 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B | Tadalafil, AUC (0-t) | 7264.28 Hour*nanogram per milliliter | Geometric Coefficient of Variation 26.6 |
| Part 1,Treatment F2 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B | Ambrisentan AUC (0-t) | 3116.10 Hour*nanogram per milliliter | Geometric Coefficient of Variation 20.3 |
| Part 1,Treatment F2 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B | Tadalafil, AUC (0-t) | 7076.48 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.4 |
90% CI: [1.0002, 1.0713]
90% CI: [0.9929, 1.0734]
Primary
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Ambrisentan, AUC (0-t) | 3297.16 Hour*nanogram per milliliter | Geometric Coefficient of Variation 19.8 |
| Part 1,Treatment F1 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Tadalafil, AUC (0-t) | 13119.89 Hour*nanogram per milliliter | Geometric Coefficient of Variation 31 |
| Part 1,Treatment F2 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Ambrisentan, AUC (0-t) | 3190.51 Hour*nanogram per milliliter | Geometric Coefficient of Variation 20.3 |
| Part 1,Treatment F2 | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Tadalafil, AUC (0-t) | 13325.63 Hour*nanogram per milliliter | Geometric Coefficient of Variation 35 |
90% CI: [1.0138, 1.0596]
90% CI: [0.9145, 1.0547]
Primary
AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, AUC (0-t) | 5926.87 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.7 |
| Part 1,Treatment F1 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, AUC (0-t) | 14366.73 Hour*nanogram per milliliter | Geometric Coefficient of Variation 33.7 |
| Part 1,Treatment F2 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, AUC (0-t) | 13320.79 Hour*nanogram per milliliter | Geometric Coefficient of Variation 32.4 |
| Part 1,Treatment F2 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, AUC (0-t) | 6090.74 Hour*nanogram per milliliter | Geometric Coefficient of Variation 24.8 |
| Part 1,Treatment F3 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, AUC (0-t) | 5766.71 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.4 |
| Part 1,Treatment F3 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, AUC (0-t) | 14946.32 Hour*nanogram per milliliter | Geometric Coefficient of Variation 31.1 |
| Part 1,Treatment F4 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, AUC (0-t) | 6012.51 Hour*nanogram per milliliter | Geometric Coefficient of Variation 24 |
| Part 1,Treatment F4 | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, AUC (0-t) | 13114.00 Hour*nanogram per milliliter | Geometric Coefficient of Variation 32.6 |
90% CI: [0.9943, 1.0623]
90% CI: [0.9832, 1.0466]
90% CI: [0.9265, 0.9972]
90% CI: [0.9562, 1.0715]
Primary
AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. PK parameter Population was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, (n=21,20,20,20) | 5893.74 Hour*nanogram per milliliter | Geometric Coefficient of Variation 29.4 |
| Part 1,Treatment F1 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, (n=20,20,20,20) | 12832.91 Hour*nanogram per milliliter | Geometric Coefficient of Variation 39.6 |
| Part 1,Treatment F2 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, (n=20,20,20,20) | 13149.19 Hour*nanogram per milliliter | Geometric Coefficient of Variation 37.5 |
| Part 1,Treatment F2 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, (n=21,20,20,20) | 6016.62 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.1 |
| Part 1,Treatment F3 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, (n=21,20,20,20) | 6051.83 Hour*nanogram per milliliter | Geometric Coefficient of Variation 29.6 |
| Part 1,Treatment F3 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, (n=20,20,20,20) | 13305.50 Hour*nanogram per milliliter | Geometric Coefficient of Variation 35.2 |
| Part 1,Treatment F4 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Ambrisentan, (n=21,20,20,20) | 6015.11 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.9 |
| Part 1,Treatment F4 | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | Tadalafil, (n=20,20,20,20) | 13275.08 Hour*nanogram per milliliter | Geometric Coefficient of Variation 33.3 |
Primary
AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples at Part 1, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. The PK Parameter Population was used for analysis. There is no formal hypotheses tested for Part 1 of the study.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Ambrisentan, (AUC 0- t) | 5418.03 Hour*nanogram per milliliter | Geometric Coefficient of Variation 22.9 |
| Part 1,Treatment F1 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Tadalafil, (AUC 0- t) | 12469.86 Hour*nanogram per milliliter | Geometric Coefficient of Variation 37.1 |
| Part 1,Treatment F2 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Ambrisentan, (AUC 0- t) | 5434.88 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.3 |
| Part 1,Treatment F2 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Tadalafil, (AUC 0- t) | 13307.95 Hour*nanogram per milliliter | Geometric Coefficient of Variation 37.4 |
| Part 1,Treatment F3 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Ambrisentan, (AUC 0- t) | 5655.75 Hour*nanogram per milliliter | Geometric Coefficient of Variation 25.5 |
| Part 1,Treatment F3 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Tadalafil, (AUC 0- t) | 13376.86 Hour*nanogram per milliliter | Geometric Coefficient of Variation 34.8 |
| Part 1,Treatment F4 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Tadalafil, (AUC 0- t) | 13238.89 Hour*nanogram per milliliter | Geometric Coefficient of Variation 33.4 |
| Part 1,Treatment F4 | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Ambrisentan, (AUC 0- t) | 5858.18 Hour*nanogram per milliliter | Geometric Coefficient of Variation 22.9 |
| Part 1, Treatment R | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Ambrisentan, (AUC 0- t) | 5605.58 Hour*nanogram per milliliter | Geometric Coefficient of Variation 20.2 |
| Part 1, Treatment R | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | Tadalafil, (AUC 0- t) | 12805.01 Hour*nanogram per milliliter | Geometric Coefficient of Variation 32.2 |
Primary
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Ambrisentan, Cmax | 405.89 Nanogram per milliliter | Geometric Coefficient of Variation 25.1 |
| Part 1,Treatment F1 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Tadalafil, Cmax | 340.63 Nanogram per milliliter | Geometric Coefficient of Variation 23.1 |
| Part 1,Treatment F2 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Ambrisentan, Cmax | 358.89 Nanogram per milliliter | Geometric Coefficient of Variation 24.5 |
| Part 1,Treatment F2 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Tadalafil, Cmax | 303.74 Nanogram per milliliter | Geometric Coefficient of Variation 22.5 |
90% CI: [1.0166, 1.2287]
90% CI: [1.0429, 1.2019]
Primary
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Ambrisentan, Cmax | 375.87 Nanogram per milliliter | Geometric Coefficient of Variation 23 |
| Part 1,Treatment F1 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Tadalafil, Cmax | 488.36 Nanogram per milliliter | Geometric Coefficient of Variation 19.7 |
| Part 1,Treatment F2 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Ambrisentan, Cmax | 380.47 Nanogram per milliliter | Geometric Coefficient of Variation 26.2 |
| Part 1,Treatment F2 | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Tadalafil, Cmax | 511.80 Nanogram per milliliter | Geometric Coefficient of Variation 28.3 |
90% CI: [0.9348, 1.1027]
90% CI: [0.9044, 1.0529]
Primary
Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, Cmax | 550.02 Nanogram per milliliter | Geometric Coefficient of Variation 30.9 |
| Part 1,Treatment F1 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, Cmax | 525.10 Nanogram per milliliter | Geometric Coefficient of Variation 26.5 |
| Part 1,Treatment F2 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, Cmax | 508.72 Nanogram per milliliter | Geometric Coefficient of Variation 24.9 |
| Part 1,Treatment F2 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, Cmax | 756.60 Nanogram per milliliter | Geometric Coefficient of Variation 24.1 |
| Part 1,Treatment F3 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, Cmax | 515.61 Nanogram per milliliter | Geometric Coefficient of Variation 33.4 |
| Part 1,Treatment F3 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, Cmax | 533.67 Nanogram per milliliter | Geometric Coefficient of Variation 19.5 |
| Part 1,Treatment F4 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Ambrisentan, Cmax | 728.32 Nanogram per milliliter | Geometric Coefficient of Variation 29.8 |
| Part 1,Treatment F4 | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Tadalafil, Cmax | 520.62 Nanogram per milliliter | Geometric Coefficient of Variation 21.1 |
90% CI: [0.9657, 1.1784]
90% CI: [0.9293, 1.1534]
90% CI: [0.9288, 1.0423]
90% CI: [0.9151, 1.0188]
Primary
Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time-points, of Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Ambrisentan, (n=21,20,20,20) | 710.90 Nanogram per milliliter | Geometric Coefficient of Variation 28.2 |
| Part 1,Treatment F1 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Tadalafil, (n=20,20,20,20) | 537.80 Nanogram per milliliter | Geometric Coefficient of Variation 27.6 |
| Part 1,Treatment F2 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Tadalafil, (n=20,20,20,20) | 561.60 Nanogram per milliliter | Geometric Coefficient of Variation 28.4 |
| Part 1,Treatment F2 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Ambrisentan, (n=21,20,20,20) | 720.79 Nanogram per milliliter | Geometric Coefficient of Variation 21.1 |
| Part 1,Treatment F3 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Ambrisentan, (n=21,20,20,20) | 748.63 Nanogram per milliliter | Geometric Coefficient of Variation 22.9 |
| Part 1,Treatment F3 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Tadalafil, (n=20,20,20,20) | 550.78 Nanogram per milliliter | Geometric Coefficient of Variation 28.6 |
| Part 1,Treatment F4 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Ambrisentan, (n=21,20,20,20) | 726.15 Nanogram per milliliter | Geometric Coefficient of Variation 31.4 |
| Part 1,Treatment F4 | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Tadalafil, (n=20,20,20,20) | 553.31 Nanogram per milliliter | Geometric Coefficient of Variation 20.5 |
Primary
Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, Cmax | 766.29 Nanogram per milliliter | Geometric Coefficient of Variation 18.2 |
| Part 1,Treatment F1 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, Cmax | 581.41 Nanogram per milliliter | Geometric Coefficient of Variation 27.6 |
| Part 1,Treatment F2 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, Cmax | 685.33 Nanogram per milliliter | Geometric Coefficient of Variation 20.5 |
| Part 1,Treatment F2 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, Cmax | 595.47 Nanogram per milliliter | Geometric Coefficient of Variation 22.3 |
| Part 1,Treatment F3 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, Cmax | 738.49 Nanogram per milliliter | Geometric Coefficient of Variation 22.1 |
| Part 1,Treatment F3 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, Cmax | 588.11 Nanogram per milliliter | Geometric Coefficient of Variation 24.5 |
| Part 1,Treatment F4 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, Cmax | 590.36 Nanogram per milliliter | Geometric Coefficient of Variation 21.4 |
| Part 1,Treatment F4 | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, Cmax | 722.57 Nanogram per milliliter | Geometric Coefficient of Variation 27.7 |
| Part 1, Treatment R | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Ambrisentan, Cmax | 755.37 Nanogram per milliliter | Geometric Coefficient of Variation 28.9 |
| Part 1, Treatment R | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Tadalafil, Cmax | 567.62 Nanogram per milliliter | Geometric Coefficient of Variation 18 |
Secondary
Change From Baseline in Vital- SBP and DBP, Part 2
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 0.5 hour | -1.57 Milliliters of Mercury | Standard Deviation 5.388 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 72 hour | 0.95 Milliliters of Mercury | Standard Deviation 8.399 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 12 hour | -3.76 Milliliters of Mercury | Standard Deviation 7.8 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 72 hour | 4.14 Milliliters of Mercury | Standard Deviation 7.636 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 48 hour | -3.29 Milliliters of Mercury | Standard Deviation 7.125 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 24 hour | -3.00 Milliliters of Mercury | Standard Deviation 7.342 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 24 hour | -2.95 Milliliters of Mercury | Standard Deviation 7.847 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 12 hour | -0.05 Milliliters of Mercury | Standard Deviation 7.292 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 2 hour | -5.67 Milliliters of Mercury | Standard Deviation 7.073 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 0.5 hour | -2.29 Milliliters of Mercury | Standard Deviation 5.396 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 8 hour | -5.43 Milliliters of Mercury | Standard Deviation 8.982 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 4 hour | -3.05 Milliliters of Mercury | Standard Deviation 7.561 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 4 hour | -4.10 Milliliters of Mercury | Standard Deviation 6.468 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 48 hour | -2.00 Milliliters of Mercury | Standard Deviation 5.82 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 2 hour | -5.52 Milliliters of Mercury | Standard Deviation 8.848 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 1 hour | -4.43 Milliliters of Mercury | Standard Deviation 8.996 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 8 hour | -4.43 Milliliters of Mercury | Standard Deviation 8.603 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 1 hour | -4.71 Milliliters of Mercury | Standard Deviation 7.329 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 2 hour | -4.98 Milliliters of Mercury | Standard Deviation 5.488 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 0.5 hour | 0.28 Milliliters of Mercury | Standard Deviation 5.707 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 1 hour | -4.23 Milliliters of Mercury | Standard Deviation 5.686 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 4 hour | -3.53 Milliliters of Mercury | Standard Deviation 7.159 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 8 hour | -2.58 Milliliters of Mercury | Standard Deviation 7.979 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 12 hour | -3.18 Milliliters of Mercury | Standard Deviation 5.669 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 24 hour | -1.03 Milliliters of Mercury | Standard Deviation 6.791 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 48 hour | 2.48 Milliliters of Mercury | Standard Deviation 6.451 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 72 hour | 3.23 Milliliters of Mercury | Standard Deviation 5.357 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 0.5 hour | 1.63 Milliliters of Mercury | Standard Deviation 5.314 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 1 hour | -3.93 Milliliters of Mercury | Standard Deviation 6.057 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 2 hour | -2.48 Milliliters of Mercury | Standard Deviation 5.683 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 4 hour | -2.13 Milliliters of Mercury | Standard Deviation 6.456 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 8 hour | -3.98 Milliliters of Mercury | Standard Deviation 7.046 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 12 hour | 4.38 Milliliters of Mercury | Standard Deviation 9.418 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 24 hour | -0.68 Milliliters of Mercury | Standard Deviation 8.307 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 48 hour | 4.78 Milliliters of Mercury | Standard Deviation 7.911 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 72 hour | 5.13 Milliliters of Mercury | Standard Deviation 7.609 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 8 hour | -5.15 Milliliters of Mercury | Standard Deviation 6.917 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 0.5 hour | 2.90 Milliliters of Mercury | Standard Deviation 4.576 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 1 hour | -2.05 Milliliters of Mercury | Standard Deviation 8 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 4 hour | -3.90 Milliliters of Mercury | Standard Deviation 7.08 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 72 hour | 5.00 Milliliters of Mercury | Standard Deviation 6.345 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 2 hour | -1.45 Milliliters of Mercury | Standard Deviation 7.112 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 48 hour | 0.85 Milliliters of Mercury | Standard Deviation 8.57 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 4 hour | -2.45 Milliliters of Mercury | Standard Deviation 7.082 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 2 hour | -5.85 Milliliters of Mercury | Standard Deviation 5.974 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 8 hour | -2.35 Milliliters of Mercury | Standard Deviation 6.471 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 0.5 hour | -0.25 Milliliters of Mercury | Standard Deviation 5.564 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 12 hour | 2.00 Milliliters of Mercury | Standard Deviation 6.951 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 1 hour | -4.55 Milliliters of Mercury | Standard Deviation 5.264 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 24 hour | -2.00 Milliliters of Mercury | Standard Deviation 6.318 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 12 hour | -2.25 Milliliters of Mercury | Standard Deviation 6.084 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 48 hour | 1.35 Milliliters of Mercury | Standard Deviation 5.956 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 24 hour | -0.30 Milliliters of Mercury | Standard Deviation 8.163 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 72 hour | 2.05 Milliliters of Mercury | Standard Deviation 6.671 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 24 hour | -5.25 Milliliters of Mercury | Standard Deviation 6.47 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 24 hour | -1.68 Milliliters of Mercury | Standard Deviation 6.218 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 8 hour | -6.38 Milliliters of Mercury | Standard Deviation 8.617 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 0.5 hour | -0.33 Milliliters of Mercury | Standard Deviation 4.913 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 4 hour | -5.10 Milliliters of Mercury | Standard Deviation 6.131 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 0.5 hour | -1.00 Milliliters of Mercury | Standard Deviation 5.091 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 1 hour | -4.35 Milliliters of Mercury | Standard Deviation 5.703 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 1 hour | -1.98 Milliliters of Mercury | Standard Deviation 7.144 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 8 hour | -5.65 Milliliters of Mercury | Standard Deviation 8.278 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 72 hour | 3.48 Milliliters of Mercury | Standard Deviation 8.367 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 12 hour | 0.83 Milliliters of Mercury | Standard Deviation 6.822 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 2 hour | -7.33 Milliliters of Mercury | Standard Deviation 9.574 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 2 hour | -7.05 Milliliters of Mercury | Standard Deviation 5.954 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 12 hour | -4.35 Milliliters of Mercury | Standard Deviation 5.912 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 72 hour | 1.50 Milliliters of Mercury | Standard Deviation 6.907 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 4 hour | -5.58 Milliliters of Mercury | Standard Deviation 6.053 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | DBP, 48 hour | 1.40 Milliliters of Mercury | Standard Deviation 4.901 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 2 | SBP, 48 hour | 2.08 Milliliters of Mercury | Standard Deviation 4.66 |
Secondary
Change From Baseline in Vital- SBP and DBP, Part 3A
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP, DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 1 hour | 2.88 Milliliters of Mercury | Standard Deviation 7.478 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 0.5 hour | 5.75 Milliliters of Mercury | Standard Deviation 5.236 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 12 hour | -7.25 Milliliters of Mercury | Standard Deviation 7.097 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 24 hour | -0.78 Milliliters of Mercury | Standard Deviation 8.974 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 72 hour | -1.56 Milliliters of Mercury | Standard Deviation 6.361 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 48 hour | -2.41 Milliliters of Mercury | Standard Deviation 9.414 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 24 hour | -7.25 Milliliters of Mercury | Standard Deviation 7.033 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 12 hour | -0.03 Milliliters of Mercury | Standard Deviation 8.372 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 2 hour | -8.97 Milliliters of Mercury | Standard Deviation 7.104 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 48 hour | 2.72 Milliliters of Mercury | Standard Deviation 8.437 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 0.5 hour | -3.47 Milliliters of Mercury | Standard Deviation 6.724 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 8 hour | -5.06 Milliliters of Mercury | Standard Deviation 9.313 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 4 hour | -8.75 Milliliters of Mercury | Standard Deviation 5.879 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 1 hour | -6.69 Milliliters of Mercury | Standard Deviation 6.509 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 4 hour | -1.72 Milliliters of Mercury | Standard Deviation 7.699 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 2 hour | 0.28 Milliliters of Mercury | Standard Deviation 9.549 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 8 hour | -8.41 Milliliters of Mercury | Standard Deviation 7.088 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 72 hour | 1.81 Milliliters of Mercury | Standard Deviation 8.538 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 8 hour | -5.32 Milliliters of Mercury | Standard Deviation 10.608 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 0.5 hour | -0.36 Milliliters of Mercury | Standard Deviation 5.821 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 1 hour | -4.73 Milliliters of Mercury | Standard Deviation 6.418 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 2 hour | -6.03 Milliliters of Mercury | Standard Deviation 5.84 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 4 hour | -6.24 Milliliters of Mercury | Standard Deviation 6.148 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 8 hour | -7.76 Milliliters of Mercury | Standard Deviation 8.1 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 12 hour | -6.18 Milliliters of Mercury | Standard Deviation 8.08 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 24 hour | -4.27 Milliliters of Mercury | Standard Deviation 6.011 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 48 hour | -0.79 Milliliters of Mercury | Standard Deviation 7.73 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 72 hour | 1.24 Milliliters of Mercury | Standard Deviation 6.544 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 0.5 hour | -0.32 Milliliters of Mercury | Standard Deviation 8.074 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 1 hour | -4.14 Milliliters of Mercury | Standard Deviation 9.772 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 2 hour | -2.05 Milliliters of Mercury | Standard Deviation 8.873 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 4 hour | -4.35 Milliliters of Mercury | Standard Deviation 9.423 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 12 hour | -0.47 Milliliters of Mercury | Standard Deviation 10.702 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 24 hour | -1.08 Milliliters of Mercury | Standard Deviation 10.4 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 48 hour | 1.68 Milliliters of Mercury | Standard Deviation 9.134 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 72 hour | 3.14 Milliliters of Mercury | Standard Deviation 11.277 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 8 hour | -5.23 Milliliters of Mercury | Standard Deviation 9.288 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 72 hour | 3.86 Milliliters of Mercury | Standard Deviation 11.332 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 48 hour | 1.36 Milliliters of Mercury | Standard Deviation 7.927 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 2 hour | -0.08 Milliliters of Mercury | Standard Deviation 7.294 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 12 hour | -1.05 Milliliters of Mercury | Standard Deviation 9.116 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 1 hour | 2.86 Milliliters of Mercury | Standard Deviation 9.186 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 4 hour | -10.30 Milliliters of Mercury | Standard Deviation 6.722 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 1 hour | -5.86 Milliliters of Mercury | Standard Deviation 7.055 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 24 hour | -4.77 Milliliters of Mercury | Standard Deviation 7.168 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 4 hour | -4.30 Milliliters of Mercury | Standard Deviation 8.27 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 8 hour | -6.45 Milliliters of Mercury | Standard Deviation 8.865 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 0.5 hour | -3.02 Milliliters of Mercury | Standard Deviation 7.779 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 48 hour | -1.89 Milliliters of Mercury | Standard Deviation 6.945 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 0.5 hour | 4.55 Milliliters of Mercury | Standard Deviation 8.543 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 12 hour | -7.67 Milliliters of Mercury | Standard Deviation 8.274 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 24 hour | -2.48 Milliliters of Mercury | Standard Deviation 6.478 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 72 hour | -1.52 Milliliters of Mercury | Standard Deviation 9.187 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 2 hour | -6.89 Milliliters of Mercury | Standard Deviation 6.173 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 72 hour | 0.80 Milliliters of Mercury | Standard Deviation 9.118 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 24 hour | -2.08 Milliliters of Mercury | Standard Deviation 7.106 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 0.5 hour | 0.17 Milliliters of Mercury | Standard Deviation 5.822 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 0.5 hour | -1.45 Milliliters of Mercury | Standard Deviation 6.943 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 1 hour | -1.95 Milliliters of Mercury | Standard Deviation 5.959 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 4 hour | -6.27 Milliliters of Mercury | Standard Deviation 7.799 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 2 hour | -3.95 Milliliters of Mercury | Standard Deviation 6.99 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 4 hour | -4.77 Milliliters of Mercury | Standard Deviation 7.717 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 2 hour | -6.05 Milliliters of Mercury | Standard Deviation 7.745 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 8 hour | -5.27 Milliliters of Mercury | Standard Deviation 7.975 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 1 hour | -5.36 Milliliters of Mercury | Standard Deviation 7.768 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 48 hour | 0.80 Milliliters of Mercury | Standard Deviation 7.661 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 12 hour | -1.58 Milliliters of Mercury | Standard Deviation 9.155 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | SBP, 72 hour | 3.52 Milliliters of Mercury | Standard Deviation 6.752 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 24 hour | -5.89 Milliliters of Mercury | Standard Deviation 6.847 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 12 hour | -7.36 Milliliters of Mercury | Standard Deviation 9.886 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 48 hour | -1.77 Milliliters of Mercury | Standard Deviation 7.503 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3A | DBP, 8 hour | -8.20 Milliliters of Mercury | Standard Deviation 8.845 |
Secondary
Change From Baseline in Vital- SBP and DBP, Part 3B
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 0.5 hour | 0.77 Milliliters of Mercury | Standard Deviation 9.323 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 72 hour | 0.85 Milliliters of Mercury | Standard Deviation 7.594 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 12 hour | -3.38 Milliliters of Mercury | Standard Deviation 8.189 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 72 hour | 2.80 Milliliters of Mercury | Standard Deviation 9.174 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 48 hour | -0.65 Milliliters of Mercury | Standard Deviation 7.945 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 24 hour | -1.62 Milliliters of Mercury | Standard Deviation 6.464 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 24 hour | -0.13 Milliliters of Mercury | Standard Deviation 8.805 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 12 hour | 2.17 Milliliters of Mercury | Standard Deviation 11.075 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 2 hour | -6.52 Milliliters of Mercury | Standard Deviation 10.758 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 0.5 hour | -1.42 Milliliters of Mercury | Standard Deviation 6.365 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 8 hour | -2.87 Milliliters of Mercury | Standard Deviation 10.059 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 4 hour | -4.17 Milliliters of Mercury | Standard Deviation 8.68 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 4 hour | -5.02 Milliliters of Mercury | Standard Deviation 4.481 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 48 hour | 5.33 Milliliters of Mercury | Standard Deviation 8.963 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 2 hour | -0.57 Milliliters of Mercury | Standard Deviation 9.657 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 1 hour | -1.27 Milliliters of Mercury | Standard Deviation 8.463 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 8 hour | -4.38 Milliliters of Mercury | Standard Deviation 8.616 |
| Part 1,Treatment F1 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 1 hour | -3.92 Milliliters of Mercury | Standard Deviation 6.443 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 2 hour | -5.92 Milliliters of Mercury | Standard Deviation 6.044 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 0.5 hour | -2.15 Milliliters of Mercury | Standard Deviation 6.582 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 1 hour | -3.31 Milliliters of Mercury | Standard Deviation 5.569 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 4 hour | -6.85 Milliliters of Mercury | Standard Deviation 5.455 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 8 hour | -6.56 Milliliters of Mercury | Standard Deviation 5.815 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 12 hour | -5.15 Milliliters of Mercury | Standard Deviation 6.431 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 24 hour | -4.05 Milliliters of Mercury | Standard Deviation 6.571 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 48 hour | -0.40 Milliliters of Mercury | Standard Deviation 6.512 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 72 hour | 0.31 Milliliters of Mercury | Standard Deviation 4.79 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 0.5 hour | -0.92 Milliliters of Mercury | Standard Deviation 8.734 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 1 hour | 0.11 Milliliters of Mercury | Standard Deviation 8.945 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 2 hour | -4.34 Milliliters of Mercury | Standard Deviation 10.254 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 4 hour | -3.92 Milliliters of Mercury | Standard Deviation 7.959 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 8 hour | -2.95 Milliliters of Mercury | Standard Deviation 11.644 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 12 hour | 0.11 Milliliters of Mercury | Standard Deviation 13.298 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 24 hour | -2.56 Milliliters of Mercury | Standard Deviation 8.996 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 48 hour | 0.50 Milliliters of Mercury | Standard Deviation 8.748 |
| Part 1,Treatment F2 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 72 hour | 1.76 Milliliters of Mercury | Standard Deviation 8.922 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 8 hour | -7.81 Milliliters of Mercury | Standard Deviation 6.258 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 0.5 hour | 0.30 Milliliters of Mercury | Standard Deviation 8.287 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 1 hour | -0.20 Milliliters of Mercury | Standard Deviation 7.893 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 4 hour | -6.56 Milliliters of Mercury | Standard Deviation 6.488 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 72 hour | 2.76 Milliliters of Mercury | Standard Deviation 7.236 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 2 hour | -1.98 Milliliters of Mercury | Standard Deviation 7.925 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 48 hour | 3.45 Milliliters of Mercury | Standard Deviation 6.139 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 4 hour | -3.14 Milliliters of Mercury | Standard Deviation 5.501 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 2 hour | -5.00 Milliliters of Mercury | Standard Deviation 5.651 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 8 hour | -3.05 Milliliters of Mercury | Standard Deviation 8.804 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 0.5 hour | -2.53 Milliliters of Mercury | Standard Deviation 5.507 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 12 hour | 0.45 Milliliters of Mercury | Standard Deviation 7.846 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 1 hour | -3.41 Milliliters of Mercury | Standard Deviation 7.157 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 24 hour | -3.31 Milliliters of Mercury | Standard Deviation 5.118 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 12 hour | -5.88 Milliliters of Mercury | Standard Deviation 6.644 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 48 hour | -0.41 Milliliters of Mercury | Standard Deviation 5.491 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 24 hour | 0.36 Milliliters of Mercury | Standard Deviation 5.21 |
| Part 1,Treatment F3 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 72 hour | -0.47 Milliliters of Mercury | Standard Deviation 6.074 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 24 hour | -4.90 Milliliters of Mercury | Standard Deviation 5.636 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 24 hour | -1.77 Milliliters of Mercury | Standard Deviation 8.458 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 8 hour | -5.03 Milliliters of Mercury | Standard Deviation 7.294 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 0.5 hour | 0.43 Milliliters of Mercury | Standard Deviation 5.157 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 4 hour | -6.80 Milliliters of Mercury | Standard Deviation 6.884 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 0.5 hour | -1.53 Milliliters of Mercury | Standard Deviation 6.965 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 1 hour | -3.73 Milliliters of Mercury | Standard Deviation 6.027 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 1 hour | 0.17 Milliliters of Mercury | Standard Deviation 6.823 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 8 hour | -7.23 Milliliters of Mercury | Standard Deviation 9.095 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 72 hour | 1.70 Milliliters of Mercury | Standard Deviation 9.502 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 12 hour | -1.03 Milliliters of Mercury | Standard Deviation 10.562 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 2 hour | -1.10 Milliliters of Mercury | Standard Deviation 4.845 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 2 hour | -5.70 Milliliters of Mercury | Standard Deviation 5.842 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 12 hour | -7.57 Milliliters of Mercury | Standard Deviation 6.494 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 72 hour | -0.93 Milliliters of Mercury | Standard Deviation 6.781 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 4 hour | -5.60 Milliliters of Mercury | Standard Deviation 7.831 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | DBP, 48 hour | -1.50 Milliliters of Mercury | Standard Deviation 7.405 |
| Part 1,Treatment F4 | Change From Baseline in Vital- SBP and DBP, Part 3B | SBP, 48 hour | 1.87 Milliliters of Mercury | Standard Deviation 8.345 |
Secondary
Change From Baseline in Vital Signs-Heart Rate, Part 1
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 4 hour | 3.26 Beats per minute | Standard Deviation 4.449 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 24 hour | 6.17 Beats per minute | Standard Deviation 4.498 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 2 hour | 3.69 Beats per minute | Standard Deviation 5.451 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 1 hour | 3.79 Beats per minute | Standard Deviation 4.314 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 72 hour | 6.21 Beats per minute | Standard Deviation 4.665 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 48 hour | 9.21 Beats per minute | Standard Deviation 5.11 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 12 hour | 10.40 Beats per minute | Standard Deviation 6.387 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 0.5 hour | 2.98 Beats per minute | Standard Deviation 4.766 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 8 hour | 8.26 Beats per minute | Standard Deviation 6.488 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 48 hour | 8.67 Beats per minute | Standard Deviation 6.539 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 72 hour | 7.54 Beats per minute | Standard Deviation 7.762 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 0.5 hour | 2.89 Beats per minute | Standard Deviation 2.558 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 2 hour | 4.41 Beats per minute | Standard Deviation 3.107 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 4 hour | 3.63 Beats per minute | Standard Deviation 3.331 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 8 hour | 7.93 Beats per minute | Standard Deviation 5.407 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 12 hour | 12.75 Beats per minute | Standard Deviation 6.141 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 24 hour | 7.02 Beats per minute | Standard Deviation 6.343 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 1 hour | 4.11 Beats per minute | Standard Deviation 2.62 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 48 hour | 7.57 Beats per minute | Standard Deviation 5.623 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 24 hour | 6.52 Beats per minute | Standard Deviation 5.371 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 8 hour | 7.17 Beats per minute | Standard Deviation 6.583 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 72 hour | 6.57 Beats per minute | Standard Deviation 7.789 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 12 hour | 10.48 Beats per minute | Standard Deviation 7.264 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 1 hour | 2.48 Beats per minute | Standard Deviation 4.981 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 2 hour | 1.91 Beats per minute | Standard Deviation 4.562 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 0.5 hour | 1.13 Beats per minute | Standard Deviation 3.181 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 4 hour | 1.52 Beats per minute | Standard Deviation 4.636 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 1 hour | 3.30 Beats per minute | Standard Deviation 3.112 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 0.5 hour | 2.98 Beats per minute | Standard Deviation 3.718 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 4 hour | 3.16 Beats per minute | Standard Deviation 5.176 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 12 hour | 11.11 Beats per minute | Standard Deviation 7.687 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 2 hour | 2.48 Beats per minute | Standard Deviation 4.393 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 8 hour | 6.11 Beats per minute | Standard Deviation 5.323 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 72 hour | 5.57 Beats per minute | Standard Deviation 7.323 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 48 hour | 6.48 Beats per minute | Standard Deviation 5.302 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 24 hour | 5.61 Beats per minute | Standard Deviation 5.381 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 72 hour | 5.03 Beats per minute | Standard Deviation 6.014 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 0.5 hour | 3.74 Beats per minute | Standard Deviation 4.024 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 1 hour | 4.17 Beats per minute | Standard Deviation 4.223 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 2 hour | 2.83 Beats per minute | Standard Deviation 4.127 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 4 hour | 2.12 Beats per minute | Standard Deviation 3.584 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 8 hour | 7.55 Beats per minute | Standard Deviation 5.522 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 12 hour | 10.83 Beats per minute | Standard Deviation 5.342 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 24 hour | 6.74 Beats per minute | Standard Deviation 7.915 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Heart Rate, Part 1 | HR, 48 hour | 7.69 Beats per minute | Standard Deviation 5.501 |
Secondary
Change From Baseline in Vital Signs-Heart Rate, Part 2
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 24 hour | 6.74 Beats per minute | Standard Deviation 6.1 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 12 hour | 17.21 Beats per minute | Standard Deviation 7.348 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 72 hour | 9.40 Beats per minute | Standard Deviation 8.412 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 4 hour | 3.36 Beats per minute | Standard Deviation 5.287 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 2 hour | 3.21 Beats per minute | Standard Deviation 3.72 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 1 hour | 3.12 Beats per minute | Standard Deviation 4.475 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 48 hour | 6.79 Beats per minute | Standard Deviation 5.361 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 8 hour | 9.36 Beats per minute | Standard Deviation 7.72 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 0.5 hour | 1.45 Beats per minute | Standard Deviation 4.04 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 8 hour | 8.30 Beats per minute | Standard Deviation 7.596 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 24 hour | 8.80 Beats per minute | Standard Deviation 6.031 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 12 hour | 14.80 Beats per minute | Standard Deviation 9.512 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 1 hour | 3.85 Beats per minute | Standard Deviation 4.665 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 0.5 hour | 2.85 Beats per minute | Standard Deviation 4.934 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 2 hour | 3.75 Beats per minute | Standard Deviation 6.568 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 72 hour | 7.90 Beats per minute | Standard Deviation 8.534 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 48 hour | 5.70 Beats per minute | Standard Deviation 4.697 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 4 hour | 5.45 Beats per minute | Standard Deviation 11.978 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 8 hour | 6.55 Beats per minute | Standard Deviation 6.901 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 0.5 hour | 1.95 Beats per minute | Standard Deviation 6.219 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 1 hour | 5.10 Beats per minute | Standard Deviation 6.528 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 2 hour | 2.75 Beats per minute | Standard Deviation 5.959 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 4 hour | 3.20 Beats per minute | Standard Deviation 7.428 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 12 hour | 15.50 Beats per minute | Standard Deviation 6.473 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 24 hour | 8.00 Beats per minute | Standard Deviation 7.395 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 48 hour | 5.10 Beats per minute | Standard Deviation 5.973 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 72 hour | 7.80 Beats per minute | Standard Deviation 8.427 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 24 hour | 8.70 Beats per minute | Standard Deviation 7.388 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 4 hour | 6.00 Beats per minute | Standard Deviation 5.978 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 2 hour | 6.45 Beats per minute | Standard Deviation 6.039 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 72 hour | 9.30 Beats per minute | Standard Deviation 7.153 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 48 hour | 5.90 Beats per minute | Standard Deviation 4.599 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 1 hour | 5.35 Beats per minute | Standard Deviation 3.208 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 12 hour | 16.45 Beats per minute | Standard Deviation 6.669 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 8 hour | 8.30 Beats per minute | Standard Deviation 9.234 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 2 | HR, 0.5 hour | 2.20 Beats per minute | Standard Deviation 3.975 |
Secondary
Change From Baseline in Vital Signs-Heart Rate, Part 3A
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 24 hour | 8.72 Beats per minute | Standard Deviation 5.341 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 12 hour | 15.28 Beats per minute | Standard Deviation 10.232 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 72 hour | 9.19 Beats per minute | Standard Deviation 6.708 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 4 hour | 10.16 Beats per minute | Standard Deviation 6.491 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 2 hour | 11.06 Beats per minute | Standard Deviation 5.891 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 1 hour | 10.28 Beats per minute | Standard Deviation 6.108 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 48 hour | 8.50 Beats per minute | Standard Deviation 4.465 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 8 hour | 9.06 Beats per minute | Standard Deviation 5.872 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 0.5 hour | 8.28 Beats per minute | Standard Deviation 5.785 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 8 hour | 10.79 Beats per minute | Standard Deviation 7.847 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 24 hour | 8.73 Beats per minute | Standard Deviation 7.048 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 12 hour | 15.91 Beats per minute | Standard Deviation 9.669 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 1 hour | 5.52 Beats per minute | Standard Deviation 4.154 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 0.5 hour | 2.64 Beats per minute | Standard Deviation 3.9 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 2 hour | 4.61 Beats per minute | Standard Deviation 4.565 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 72 hour | 10.91 Beats per minute | Standard Deviation 10.476 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 48 hour | 9.45 Beats per minute | Standard Deviation 7.527 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 4 hour | 5.06 Beats per minute | Standard Deviation 6.91 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 8 hour | 10.16 Beats per minute | Standard Deviation 7.407 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 0.5 hour | 10.66 Beats per minute | Standard Deviation 4.717 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 1 hour | 12.97 Beats per minute | Standard Deviation 6.573 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 2 hour | 11.41 Beats per minute | Standard Deviation 6.439 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 4 hour | 10.91 Beats per minute | Standard Deviation 5.431 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 12 hour | 14.38 Beats per minute | Standard Deviation 10.204 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 24 hour | 7.00 Beats per minute | Standard Deviation 6.673 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 48 hour | 9.47 Beats per minute | Standard Deviation 7.301 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 72 hour | 9.59 Beats per minute | Standard Deviation 9.088 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 24 hour | 7.28 Beats per minute | Standard Deviation 4.704 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 4 hour | 4.44 Beats per minute | Standard Deviation 4.629 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 2 hour | 4.16 Beats per minute | Standard Deviation 4.306 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 72 hour | 10.03 Beats per minute | Standard Deviation 8.041 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 48 hour | 8.03 Beats per minute | Standard Deviation 5.29 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 1 hour | 4.66 Beats per minute | Standard Deviation 3.897 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 12 hour | 16.38 Beats per minute | Standard Deviation 8.917 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 8 hour | 8.56 Beats per minute | Standard Deviation 6.624 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3A | HR, 0.5 hour | 2.81 Beats per minute | Standard Deviation 4.156 |
Secondary
Change From Baseline in Vital Signs-Heart Rate, Part 3B
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for HR. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 2 hour | 6.08 Beats per minute | Standard Deviation 5.706 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 12 hour | 15.85 Beats per minute | Standard Deviation 9.232 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 8 hour | 9.65 Beats per minute | Standard Deviation 8.102 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 0.5 hour | 3.05 Beats per minute | Standard Deviation 5.103 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 4 hour | 4.85 Beats per minute | Standard Deviation 6.498 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 72 hour | 10.78 Beats per minute | Standard Deviation 8.397 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 48 hour | 9.72 Beats per minute | Standard Deviation 5.845 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 1 hour | 6.05 Beats per minute | Standard Deviation 5.784 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 24 hour | 8.02 Beats per minute | Standard Deviation 6.086 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 24 hour | 6.92 Beats per minute | Standard Deviation 6.162 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 48 hour | 8.18 Beats per minute | Standard Deviation 6.657 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 72 hour | 9.18 Beats per minute | Standard Deviation 7.853 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 0.5 hour | 3.50 Beats per minute | Standard Deviation 4.911 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 2 hour | 3.76 Beats per minute | Standard Deviation 5.524 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 4 hour | 3.69 Beats per minute | Standard Deviation 7.253 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 8 hour | 7.34 Beats per minute | Standard Deviation 6.462 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 12 hour | 15.50 Beats per minute | Standard Deviation 6.925 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 1 hour | 4.92 Beats per minute | Standard Deviation 5.496 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 24 hour | 7.77 Beats per minute | Standard Deviation 6.677 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 8 hour | 7.23 Beats per minute | Standard Deviation 6.453 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 72 hour | 7.37 Beats per minute | Standard Deviation 7.256 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 1 hour | 5.70 Beats per minute | Standard Deviation 4.621 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 48 hour | 8.08 Beats per minute | Standard Deviation 6.61 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 12 hour | 13.89 Beats per minute | Standard Deviation 7.574 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 4 hour | 4.95 Beats per minute | Standard Deviation 5.564 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 0.5 hour | 2.61 Beats per minute | Standard Deviation 4.652 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 2 hour | 5.67 Beats per minute | Standard Deviation 4.148 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 72 hour | 9.62 Beats per minute | Standard Deviation 7.245 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 0.5 hour | 2.78 Beats per minute | Standard Deviation 4.928 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 1 hour | 5.48 Beats per minute | Standard Deviation 7.515 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 2 hour | 5.58 Beats per minute | Standard Deviation 7.157 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 4 hour | 6.22 Beats per minute | Standard Deviation 4.836 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 8 hour | 8.78 Beats per minute | Standard Deviation 8.137 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 12 hour | 16.62 Beats per minute | Standard Deviation 7.8 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 48 hour | 10.15 Beats per minute | Standard Deviation 9.207 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Heart Rate, Part 3B | HR, 24 hour | 7.72 Beats per minute | Standard Deviation 5.7 |
Secondary
Change From Baseline in Vital Signs-Respiratory Rate, Part 1
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 48 hour | 0.2 Breaths per minute | Standard Deviation 2.68 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 2 hour | -0.0 Breaths per minute | Standard Deviation 1.56 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 12 hour | 0.5 Breaths per minute | Standard Deviation 2.86 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 0.5 hour | -0.5 Breaths per minute | Standard Deviation 2.23 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 1 hour | -0.5 Breaths per minute | Standard Deviation 2.62 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 24 hour | -0.5 Breaths per minute | Standard Deviation 2.44 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 4 hour | -1.0 Breaths per minute | Standard Deviation 2.1 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 8 hour | 0.1 Breaths per minute | Standard Deviation 2.73 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 72 hour | -0.8 Breaths per minute | Standard Deviation 2.44 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 72 hour | -0.1 Breaths per minute | Standard Deviation 3.38 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 12 hour | 0.4 Breaths per minute | Standard Deviation 1.81 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 8 hour | 0.2 Breaths per minute | Standard Deviation 2.33 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 0.5 hour | -0.7 Breaths per minute | Standard Deviation 2.38 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 48 hour | -0.6 Breaths per minute | Standard Deviation 2.52 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 2 hour | -1.0 Breaths per minute | Standard Deviation 2.08 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 24 hour | -0.7 Breaths per minute | Standard Deviation 2.22 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 4 hour | -0.8 Breaths per minute | Standard Deviation 1.98 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 1 hour | -1.0 Breaths per minute | Standard Deviation 2.69 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 12 hour | 0.3 Breaths per minute | Standard Deviation 2.93 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 0.5 hour | -0.1 Breaths per minute | Standard Deviation 3.17 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 1 hour | 0.0 Breaths per minute | Standard Deviation 2.76 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 2 hour | -0.2 Breaths per minute | Standard Deviation 2.55 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 4 hour | -0.5 Breaths per minute | Standard Deviation 2.91 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 8 hour | 0.0 Breaths per minute | Standard Deviation 2.63 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 24 hour | -0.4 Breaths per minute | Standard Deviation 2.63 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 48 hour | 0.4 Breaths per minute | Standard Deviation 3.07 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 72 hour | 0.7 Breaths per minute | Standard Deviation 3.17 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 4 hour | 0.2 Breaths per minute | Standard Deviation 2.54 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 12 hour | 0.9 Breaths per minute | Standard Deviation 2.94 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 2 hour | 0.4 Breaths per minute | Standard Deviation 2.48 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 24 hour | -0.1 Breaths per minute | Standard Deviation 2.35 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 1 hour | 0.6 Breaths per minute | Standard Deviation 2.72 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 72 hour | 1.0 Breaths per minute | Standard Deviation 2.6 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 48 hour | -0.0 Breaths per minute | Standard Deviation 2.55 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 0.5 hour | 0.3 Breaths per minute | Standard Deviation 1.88 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 8 hour | 0.6 Breaths per minute | Standard Deviation 2.42 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 0.5 hour | 1.1 Breaths per minute | Standard Deviation 1.49 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 4 hour | 0.4 Breaths per minute | Standard Deviation 2.42 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 12 hour | 1.7 Breaths per minute | Standard Deviation 3.3 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 2 hour | 0.5 Breaths per minute | Standard Deviation 2.44 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 8 hour | 0.6 Breaths per minute | Standard Deviation 2.2 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 72 hour | 0.8 Breaths per minute | Standard Deviation 2.46 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 48 hour | 0.3 Breaths per minute | Standard Deviation 3.86 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 24 hour | 1.0 Breaths per minute | Standard Deviation 3.2 |
| Part 1, Treatment R | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Respiratory rate, 1 hour | 0.6 Breaths per minute | Standard Deviation 2.11 |
Secondary
Change From Baseline in Vital Signs-Respiratory Rate, Part 2
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 24 hour | -0.1 Breaths per minute | Standard Deviation 3 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 12 hour | 0.8 Breaths per minute | Standard Deviation 2.93 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 72 hour | 0.2 Breaths per minute | Standard Deviation 2.79 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 4 hour | -0.1 Breaths per minute | Standard Deviation 2.87 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 2 hour | -0.6 Breaths per minute | Standard Deviation 3.32 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 1 hour | -0.9 Breaths per minute | Standard Deviation 2.15 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 48 hour | -0.5 Breaths per minute | Standard Deviation 2.6 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 8 hour | 0.1 Breaths per minute | Standard Deviation 3 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 0.5 hour | 0.7 Breaths per minute | Standard Deviation 2.92 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 8 hour | 0.5 Breaths per minute | Standard Deviation 2.82 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 24 hour | -0.3 Breaths per minute | Standard Deviation 2.92 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 12 hour | 0.2 Breaths per minute | Standard Deviation 2.46 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 1 hour | -0.4 Breaths per minute | Standard Deviation 2.56 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 0.5 hour | -0.7 Breaths per minute | Standard Deviation 2.27 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 2 hour | -1.2 Breaths per minute | Standard Deviation 2.86 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 72 hour | 0.6 Breaths per minute | Standard Deviation 2.67 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 48 hour | -0.2 Breaths per minute | Standard Deviation 2.14 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 4 hour | -0.1 Breaths per minute | Standard Deviation 3.34 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 8 hour | 0.4 Breaths per minute | Standard Deviation 2.37 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 0.5 hour | 0.3 Breaths per minute | Standard Deviation 2.85 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 1 hour | 0.3 Breaths per minute | Standard Deviation 2.7 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 2 hour | 0.4 Breaths per minute | Standard Deviation 3.41 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 4 hour | -0.1 Breaths per minute | Standard Deviation 3.21 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 12 hour | 0.8 Breaths per minute | Standard Deviation 2.61 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 24 hour | 1.3 Breaths per minute | Standard Deviation 2.7 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 48 hour | 0.7 Breaths per minute | Standard Deviation 2.62 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 72 hour | 0.6 Breaths per minute | Standard Deviation 2.91 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 24 hour | 0.4 Breaths per minute | Standard Deviation 2.32 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 4 hour | -1.0 Breaths per minute | Standard Deviation 2.5 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 2 hour | -1.1 Breaths per minute | Standard Deviation 2.7 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 72 hour | 0.6 Breaths per minute | Standard Deviation 2.82 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 48 hour | -0.6 Breaths per minute | Standard Deviation 2.24 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 1 hour | -0.7 Breaths per minute | Standard Deviation 2.21 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 12 hour | -0.5 Breaths per minute | Standard Deviation 2.87 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 8 hour | -0.5 Breaths per minute | Standard Deviation 2.06 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Respiratory rate, 0.5 hour | -1.1 Breaths per minute | Standard Deviation 2.04 |
Secondary
Change From Baseline in Vital Signs-Respiratory Rate, Part 3A
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 24 hour | -0.5 Breaths per minute | Standard Deviation 3.14 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 12 hour | 0.9 Breaths per minute | Standard Deviation 3.21 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 72 hour | 0.6 Breaths per minute | Standard Deviation 2.79 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 4 hour | 0.6 Breaths per minute | Standard Deviation 2.76 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 2 hour | 0.7 Breaths per minute | Standard Deviation 2.72 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 1 hour | 0.9 Breaths per minute | Standard Deviation 2.83 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 48 hour | 0.0 Breaths per minute | Standard Deviation 2.03 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 8 hour | 0.1 Breaths per minute | Standard Deviation 2.85 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 0.5 hour | 0.4 Breaths per minute | Standard Deviation 2.51 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 8 hour | 0.1 Breaths per minute | Standard Deviation 2.15 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 24 hour | 0.1 Breaths per minute | Standard Deviation 2.26 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 12 hour | 0.5 Breaths per minute | Standard Deviation 2.33 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 1 hour | 0.2 Breaths per minute | Standard Deviation 2.57 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 0.5 hour | 0.8 Breaths per minute | Standard Deviation 1.95 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 2 hour | 0.7 Breaths per minute | Standard Deviation 2.59 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 72 hour | 0.3 Breaths per minute | Standard Deviation 3.05 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 48 hour | -0.1 Breaths per minute | Standard Deviation 2.45 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 4 hour | 0.2 Breaths per minute | Standard Deviation 2.21 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 8 hour | 0.5 Breaths per minute | Standard Deviation 2.49 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 0.5 hour | 1.5 Breaths per minute | Standard Deviation 2.66 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 1 hour | 0.8 Breaths per minute | Standard Deviation 2.26 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 2 hour | 0.6 Breaths per minute | Standard Deviation 2.3 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 4 hour | 1.1 Breaths per minute | Standard Deviation 2.59 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 12 hour | 0.6 Breaths per minute | Standard Deviation 2.97 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 24 hour | 0.2 Breaths per minute | Standard Deviation 2.75 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 48 hour | 0.6 Breaths per minute | Standard Deviation 2.93 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 72 hour | 0.8 Breaths per minute | Standard Deviation 1.96 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 24 hour | -1.3 Breaths per minute | Standard Deviation 2.58 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 4 hour | 0.1 Breaths per minute | Standard Deviation 2.31 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 2 hour | 0.2 Breaths per minute | Standard Deviation 2.89 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 72 hour | 0.1 Breaths per minute | Standard Deviation 2.59 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 48 hour | -0.7 Breaths per minute | Standard Deviation 2.07 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 1 hour | -0.7 Breaths per minute | Standard Deviation 2.13 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 12 hour | 0.4 Breaths per minute | Standard Deviation 3.11 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 8 hour | -0.3 Breaths per minute | Standard Deviation 2.04 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Respiratory rate, 0.5 hour | -0.2 Breaths per minute | Standard Deviation 2.46 |
Secondary
Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 24 hour(n=30,31,32,30) | -1.3 Breaths per minute | Standard Deviation 3.29 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 12 hour (n=30,31,32,30) | -0.8 Breaths per minute | Standard Deviation 2.67 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 72 hour (n=30,31,31,30) | -0.1 Breaths per minute | Standard Deviation 3.73 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 4 hour (n=30,31,32,30) | 0.3 Breaths per minute | Standard Deviation 2.68 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 2 hour (n=30,31,32,30) | -0.2 Breaths per minute | Standard Deviation 2.93 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 1 hour (n=30,31,32,30) | -0.6 Breaths per minute | Standard Deviation 2.88 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 48 hour(n=30,31,32,30) | -0.8 Breaths per minute | Standard Deviation 2.81 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 8 hour(n=30,31,32,30) | 0.4 Breaths per minute | Standard Deviation 2.5 |
| Part 1,Treatment F1 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 0.5 hour (n=30,31,32,30) | -0.3 Breaths per minute | Standard Deviation 2.78 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 8 hour(n=30,31,32,30) | 0.9 Breaths per minute | Standard Deviation 3.31 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 24 hour(n=30,31,32,30) | -0.7 Breaths per minute | Standard Deviation 3.08 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 12 hour (n=30,31,32,30) | -0.3 Breaths per minute | Standard Deviation 2.82 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 1 hour (n=30,31,32,30) | -0.7 Breaths per minute | Standard Deviation 3.08 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 0.5 hour (n=30,31,32,30) | 0.4 Breaths per minute | Standard Deviation 2.99 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 2 hour (n=30,31,32,30) | 0.6 Breaths per minute | Standard Deviation 3.64 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 72 hour (n=30,31,31,30) | -0.0 Breaths per minute | Standard Deviation 2.95 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 48 hour(n=30,31,32,30) | -0.0 Breaths per minute | Standard Deviation 3.35 |
| Part 1,Treatment F2 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 4 hour (n=30,31,32,30) | 0.1 Breaths per minute | Standard Deviation 3.47 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 8 hour(n=30,31,32,30) | 0.0 Breaths per minute | Standard Deviation 3.41 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 0.5 hour (n=30,31,32,30) | -0.8 Breaths per minute | Standard Deviation 3.08 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 1 hour (n=30,31,32,30) | -0.1 Breaths per minute | Standard Deviation 2.98 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 2 hour (n=30,31,32,30) | -0.1 Breaths per minute | Standard Deviation 3.2 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 4 hour (n=30,31,32,30) | -0.4 Breaths per minute | Standard Deviation 2.85 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 12 hour (n=30,31,32,30) | 0.2 Breaths per minute | Standard Deviation 2.96 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 24 hour(n=30,31,32,30) | -0.6 Breaths per minute | Standard Deviation 2.5 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 48 hour(n=30,31,32,30) | -0.1 Breaths per minute | Standard Deviation 3.15 |
| Part 1,Treatment F3 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 72 hour (n=30,31,31,30) | 0.2 Breaths per minute | Standard Deviation 2.89 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 24 hour(n=30,31,32,30) | 0.1 Breaths per minute | Standard Deviation 3.04 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 4 hour (n=30,31,32,30) | 0.5 Breaths per minute | Standard Deviation 2.76 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 2 hour (n=30,31,32,30) | 0.6 Breaths per minute | Standard Deviation 2.31 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 72 hour (n=30,31,31,30) | 0.6 Breaths per minute | Standard Deviation 2.85 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 48 hour(n=30,31,32,30) | 1.2 Breaths per minute | Standard Deviation 3.09 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 1 hour (n=30,31,32,30) | 0.2 Breaths per minute | Standard Deviation 2.06 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 12 hour (n=30,31,32,30) | 1.1 Breaths per minute | Standard Deviation 2.89 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 8 hour(n=30,31,32,30) | 0.5 Breaths per minute | Standard Deviation 2.75 |
| Part 1,Treatment F4 | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Respiratory rate, 0.5 hour (n=30,31,32,30) | 0.8 Breaths per minute | Standard Deviation 3.06 |
Secondary
Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 48 hour | -2.38 Milliliters of Mercury | Standard Deviation 5.232 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 24 hour | -5.86 Milliliters of Mercury | Standard Deviation 7.004 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 8 hour | -9.10 Milliliters of Mercury | Standard Deviation 9.963 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 24 hour | -1.48 Milliliters of Mercury | Standard Deviation 6.541 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 12 hour | -4.76 Milliliters of Mercury | Standard Deviation 7.604 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 1 hour | -5.33 Milliliters of Mercury | Standard Deviation 6.516 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 72 hour | 6.95 Milliliters of Mercury | Standard Deviation 7.048 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 12 hour | 0.14 Milliliters of Mercury | Standard Deviation 8.755 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 8 hour | -6.10 Milliliters of Mercury | Standard Deviation 8.77 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 4 hour | -3.90 Milliliters of Mercury | Standard Deviation 7.143 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 2 hour | -5.24 Milliliters of Mercury | Standard Deviation 7.118 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 0.5 hour | -3.33 Milliliters of Mercury | Standard Deviation 6.626 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 2 hour | -6.05 Milliliters of Mercury | Standard Deviation 9.822 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 1 hour | -2.76 Milliliters of Mercury | Standard Deviation 8.153 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 0.5 hour | -1.10 Milliliters of Mercury | Standard Deviation 7.521 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 4 hour | -4.29 Milliliters of Mercury | Standard Deviation 5.205 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 48 hour | 1.52 Milliliters of Mercury | Standard Deviation 9.052 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 72 hour | 0.76 Milliliters of Mercury | Standard Deviation 5.845 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 2 hour | -5.28 Milliliters of Mercury | Standard Deviation 5.22 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 0.5 hour | -3.54 Milliliters of Mercury | Standard Deviation 4.164 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 1 hour | -4.72 Milliliters of Mercury | Standard Deviation 4.008 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 4 hour | -5.72 Milliliters of Mercury | Standard Deviation 4.064 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 8 hour | -6.67 Milliliters of Mercury | Standard Deviation 6.704 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 12 hour | -6.16 Milliliters of Mercury | Standard Deviation 5.685 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 24 hour | -4.50 Milliliters of Mercury | Standard Deviation 6.308 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 48 hour | -1.02 Milliliters of Mercury | Standard Deviation 6.091 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 72 hour | -0.67 Milliliters of Mercury | Standard Deviation 5.676 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 0.5 hour | -3.22 Milliliters of Mercury | Standard Deviation 8.59 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 1 hour | -4.13 Milliliters of Mercury | Standard Deviation 7.091 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 2 hour | -5.39 Milliliters of Mercury | Standard Deviation 7.116 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 4 hour | -7.30 Milliliters of Mercury | Standard Deviation 8.244 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 8 hour | -5.48 Milliliters of Mercury | Standard Deviation 9.279 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 12 hour | -0.84 Milliliters of Mercury | Standard Deviation 9.278 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 24 hour | -3.17 Milliliters of Mercury | Standard Deviation 9.767 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 48 hour | 2.39 Milliliters of Mercury | Standard Deviation 7.01 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 72 hour | 3.52 Milliliters of Mercury | Standard Deviation 8.993 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 72 hour | 3.37 Milliliters of Mercury | Standard Deviation 8.801 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 2 hour | -5.98 Milliliters of Mercury | Standard Deviation 3.632 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 12 hour | -5.72 Milliliters of Mercury | Standard Deviation 5.994 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 2 hour | -3.11 Milliliters of Mercury | Standard Deviation 6.098 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 24 hour | 0.02 Milliliters of Mercury | Standard Deviation 7.77 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 12 hour | 0.54 Milliliters of Mercury | Standard Deviation 9.72 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 1 hour | -5.63 Milliliters of Mercury | Standard Deviation 3.938 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 8 hour | -4.02 Milliliters of Mercury | Standard Deviation 7.346 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 4 hour | -5.50 Milliliters of Mercury | Standard Deviation 5.671 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 4 hour | -6.07 Milliliters of Mercury | Standard Deviation 6.031 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 0.5 hour | -4.20 Milliliters of Mercury | Standard Deviation 5.622 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 0.5 hour | -1.59 Milliliters of Mercury | Standard Deviation 5.441 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 48 hour | -4.02 Milliliters of Mercury | Standard Deviation 6.589 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 8 hour | -6.50 Milliliters of Mercury | Standard Deviation 5.61 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 72 hour | 0.20 Milliliters of Mercury | Standard Deviation 7.371 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 48 hour | 2.50 Milliliters of Mercury | Standard Deviation 8.577 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 1 hour | -2.54 Milliliters of Mercury | Standard Deviation 7.662 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 24 hour | -4.07 Milliliters of Mercury | Standard Deviation 5.792 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 8 hour | -9.68 Milliliters of Mercury | Standard Deviation 6.263 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 48 hour | -4.18 Milliliters of Mercury | Standard Deviation 4.382 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 0.5 hour | -2.86 Milliliters of Mercury | Standard Deviation 5.33 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 72 hour | -1.73 Milliliters of Mercury | Standard Deviation 5.311 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 72 hour | 4.18 Milliliters of Mercury | Standard Deviation 7.341 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 0.5 hour | -3.68 Milliliters of Mercury | Standard Deviation 6.438 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 2 hour | -7.27 Milliliters of Mercury | Standard Deviation 5.101 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 1 hour | -6.00 Milliliters of Mercury | Standard Deviation 7.624 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 48 hour | -0.64 Milliliters of Mercury | Standard Deviation 7.315 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 2 hour | -6.91 Milliliters of Mercury | Standard Deviation 9.148 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 4 hour | -6.59 Milliliters of Mercury | Standard Deviation 7.699 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 1 hour | -5.73 Milliliters of Mercury | Standard Deviation 6.001 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 8 hour | -10.55 Milliliters of Mercury | Standard Deviation 9.579 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 12 hour | -4.77 Milliliters of Mercury | Standard Deviation 12.023 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 12 hour | -8.18 Milliliters of Mercury | Standard Deviation 8.296 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 24 hour | -3.82 Milliliters of Mercury | Standard Deviation 7.276 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 24 hour | -5.59 Milliliters of Mercury | Standard Deviation 6.235 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 4 hour | -7.09 Milliliters of Mercury | Standard Deviation 5.149 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 2 hour | -5.40 Milliliters of Mercury | Standard Deviation 4.543 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 24 hour | -3.55 Milliliters of Mercury | Standard Deviation 5.987 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 12 hour | -3.60 Milliliters of Mercury | Standard Deviation 8.185 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 0.5 hour | -2.79 Milliliters of Mercury | Standard Deviation 7.737 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 1 hour | -3.74 Milliliters of Mercury | Standard Deviation 6.549 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 24 hour | -1.79 Milliliters of Mercury | Standard Deviation 6.758 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 8 hour | -7.83 Milliliters of Mercury | Standard Deviation 6.487 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 0.5 hour | -3.36 Milliliters of Mercury | Standard Deviation 4.953 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 2 hour | -5.83 Milliliters of Mercury | Standard Deviation 4.856 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 72 hour | -0.15 Milliliters of Mercury | Standard Deviation 6.556 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 48 hour | -0.74 Milliliters of Mercury | Standard Deviation 6.644 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 12 hour | -5.60 Milliliters of Mercury | Standard Deviation 7.687 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 4 hour | -5.36 Milliliters of Mercury | Standard Deviation 7.892 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 48 hour | -0.31 Milliliters of Mercury | Standard Deviation 8.71 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 4 hour | -5.21 Milliliters of Mercury | Standard Deviation 6.059 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 8 hour | -8.40 Milliliters of Mercury | Standard Deviation 8.434 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | DBP, 1 hour | -4.40 Milliliters of Mercury | Standard Deviation 4.705 |
| Part 1, Treatment R | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | SBP, 72 hour | 3.00 Milliliters of Mercury | Standard Deviation 7.854 |
Secondary
Change From Baseline in Vital- Temperature, Part 1
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 72 hour | 0.12 Degree celsius | Standard Deviation 0.351 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 8 hour | -0.04 Degree celsius | Standard Deviation 0.46 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 1 hour | -0.15 Degree celsius | Standard Deviation 0.275 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 12 hour | 0.09 Degree celsius | Standard Deviation 0.371 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 48 hour | -0.01 Degree celsius | Standard Deviation 0.371 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 2 hour | -0.14 Degree celsius | Standard Deviation 0.271 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 24 hour | -0.04 Degree celsius | Standard Deviation 0.273 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 4 hour | -0.28 Degree celsius | Standard Deviation 0.363 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 0.5 hour | -0.20 Degree celsius | Standard Deviation 0.22 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 24 hour | 0.03 Degree celsius | Standard Deviation 0.328 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 12 hour | 0.16 Degree celsius | Standard Deviation 0.386 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 4 hour | -0.08 Degree celsius | Standard Deviation 0.326 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 8 hour | 0.03 Degree celsius | Standard Deviation 0.438 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 2 hour | -0.16 Degree celsius | Standard Deviation 0.383 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 72 hour | 0.03 Degree celsius | Standard Deviation 0.503 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 1 hour | -0.09 Degree celsius | Standard Deviation 0.343 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 0.5 hour | -0.05 Degree celsius | Standard Deviation 0.25 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 48 hour | 0.18 Degree celsius | Standard Deviation 0.404 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 12 hour | -0.03 Degree celsius | Standard Deviation 0.438 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 0.5 hour | -0.12 Degree celsius | Standard Deviation 0.233 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 1 hour | -0.07 Degree celsius | Standard Deviation 0.216 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 2 hour | -0.23 Degree celsius | Standard Deviation 0.392 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 4 hour | -0.17 Degree celsius | Standard Deviation 0.328 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 8 hour | -0.08 Degree celsius | Standard Deviation 0.4 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 24 hour | 0.14 Degree celsius | Standard Deviation 0.39 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 48 hour | 0.01 Degree celsius | Standard Deviation 0.393 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 72 hour | -0.02 Degree celsius | Standard Deviation 0.392 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 4 hour | -0.03 Degree celsius | Standard Deviation 0.331 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 12 hour | 0.08 Degree celsius | Standard Deviation 0.405 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 2 hour | -0.04 Degree celsius | Standard Deviation 0.473 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 24 hour | 0.13 Degree celsius | Standard Deviation 0.413 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 1 hour | -0.06 Degree celsius | Standard Deviation 0.426 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 72 hour | 0.10 Degree celsius | Standard Deviation 0.424 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 48 hour | 0.05 Degree celsius | Standard Deviation 0.571 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 0.5 hour | -0.18 Degree celsius | Standard Deviation 0.357 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 8 hour | 0.08 Degree celsius | Standard Deviation 0.422 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 0.5 hour | -0.03 Degree celsius | Standard Deviation 0.201 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 4 hour | -0.10 Degree celsius | Standard Deviation 0.381 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 12 hour | 0.02 Degree celsius | Standard Deviation 0.597 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 2 hour | -0.14 Degree celsius | Standard Deviation 0.393 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 8 hour | 0.02 Degree celsius | Standard Deviation 0.408 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 72 hour | 0.02 Degree celsius | Standard Deviation 0.506 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 48 hour | 0.16 Degree celsius | Standard Deviation 0.508 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 24 hour | 0.07 Degree celsius | Standard Deviation 0.543 |
| Part 1, Treatment R | Change From Baseline in Vital- Temperature, Part 1 | Temperature, 1 hour | -0.12 Degree celsius | Standard Deviation 0.386 |
Secondary
Change From Baseline in Vital- Temperature, Part 2
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 24 hour | -0.06 Degree celsius | Standard Deviation 0.285 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 0.5 hour | -0.07 Degree celsius | Standard Deviation 0.403 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 12 hour | 0.20 Degree celsius | Standard Deviation 0.409 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 4 hour | -0.01 Degree celsius | Standard Deviation 0.348 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 72 hour | -0.09 Degree celsius | Standard Deviation 0.435 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 2 hour | -0.12 Degree celsius | Standard Deviation 0.349 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 48 hour | -0.06 Degree celsius | Standard Deviation 0.441 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 8 hour | 0.02 Degree celsius | Standard Deviation 0.397 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 1 hour | -0.13 Degree celsius | Standard Deviation 0.28 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 8 hour | -0.08 Degree celsius | Standard Deviation 0.375 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 24 hour | -0.02 Degree celsius | Standard Deviation 0.373 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 12 hour | 0.04 Degree celsius | Standard Deviation 0.437 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 1 hour | -0.11 Degree celsius | Standard Deviation 0.301 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 0.5 hour | -0.02 Degree celsius | Standard Deviation 0.281 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 2 hour | -0.17 Degree celsius | Standard Deviation 0.279 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 48 hour | -0.06 Degree celsius | Standard Deviation 0.312 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 4 hour | -0.06 Degree celsius | Standard Deviation 0.366 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 72 hour | -0.13 Degree celsius | Standard Deviation 0.49 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 8 hour | 0.05 Degree celsius | Standard Deviation 0.343 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 0.5 hour | -0.05 Degree celsius | Standard Deviation 0.261 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 1 hour | -0.01 Degree celsius | Standard Deviation 0.3 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 2 hour | -0.03 Degree celsius | Standard Deviation 0.31 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 4 hour | 0.03 Degree celsius | Standard Deviation 0.286 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 12 hour | 0.09 Degree celsius | Standard Deviation 0.418 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 24 hour | 0.24 Degree celsius | Standard Deviation 0.298 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 48 hour | 0.03 Degree celsius | Standard Deviation 0.353 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 72 hour | 0.05 Degree celsius | Standard Deviation 0.375 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 24 hour | 0.07 Degree celsius | Standard Deviation 0.4 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 4 hour | -0.19 Degree celsius | Standard Deviation 0.399 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 2 hour | -0.23 Degree celsius | Standard Deviation 0.397 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 72 hour | 0.06 Degree celsius | Standard Deviation 0.366 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 48 hour | -0.11 Degree celsius | Standard Deviation 0.488 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 1 hour | -0.04 Degree celsius | Standard Deviation 0.342 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 12 hour | 0.10 Degree celsius | Standard Deviation 0.494 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 8 hour | 0.03 Degree celsius | Standard Deviation 0.425 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 2 | Temperature, 0.5 hour | -0.14 Degree celsius | Standard Deviation 0.339 |
Secondary
Change From Baseline in Vital- Temperature, Part 3A
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 24 hour | 0.29 Degree Celsius | Standard Deviation 0.429 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 12 hour | 0.22 Degree Celsius | Standard Deviation 0.409 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 72 hour | 0.18 Degree Celsius | Standard Deviation 0.414 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 4 hour | 0.18 Degree Celsius | Standard Deviation 0.352 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 2 hour | 0.26 Degree Celsius | Standard Deviation 0.278 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 1 hour | 0.18 Degree Celsius | Standard Deviation 0.252 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 48 hour | 0.34 Degree Celsius | Standard Deviation 0.713 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 8 hour | 0.21 Degree Celsius | Standard Deviation 0.45 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 0.5 hour | 0.21 Degree Celsius | Standard Deviation 0.288 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 8 hour | 0.12 Degree Celsius | Standard Deviation 0.425 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 24 hour | 0.25 Degree Celsius | Standard Deviation 0.351 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 12 hour | 0.27 Degree Celsius | Standard Deviation 0.392 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 1 hour | 0.07 Degree Celsius | Standard Deviation 0.315 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 0.5 hour | 0.01 Degree Celsius | Standard Deviation 0.344 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 2 hour | 0.05 Degree Celsius | Standard Deviation 0.268 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 72 hour | 0.20 Degree Celsius | Standard Deviation 0.334 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 48 hour | 0.28 Degree Celsius | Standard Deviation 0.473 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 4 hour | 0.15 Degree Celsius | Standard Deviation 0.299 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 8 hour | 0.15 Degree Celsius | Standard Deviation 0.409 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 0.5 hour | 0.15 Degree Celsius | Standard Deviation 0.306 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 1 hour | 0.12 Degree Celsius | Standard Deviation 0.262 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 2 hour | 0.10 Degree Celsius | Standard Deviation 0.244 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 4 hour | 0.16 Degree Celsius | Standard Deviation 0.305 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 12 hour | 0.09 Degree Celsius | Standard Deviation 0.366 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 24 hour | 0.06 Degree Celsius | Standard Deviation 0.332 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 48 hour | 0.12 Degree Celsius | Standard Deviation 0.358 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 72 hour | 0.10 Degree Celsius | Standard Deviation 0.418 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 24 hour | 0.16 Degree Celsius | Standard Deviation 0.362 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 4 hour | -0.01 Degree Celsius | Standard Deviation 0.402 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 2 hour | 0.07 Degree Celsius | Standard Deviation 0.317 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 72 hour | 0.18 Degree Celsius | Standard Deviation 0.52 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 48 hour | 0.32 Degree Celsius | Standard Deviation 0.327 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 1 hour | 0.04 Degree Celsius | Standard Deviation 0.282 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 12 hour | 0.27 Degree Celsius | Standard Deviation 0.492 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 8 hour | 0.15 Degree Celsius | Standard Deviation 0.504 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3A | Temperature, 0.5 hour | 0.12 Degree Celsius | Standard Deviation 0.303 |
Secondary
Change From Baseline in Vital- Temperature, Part 3B
Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.
Time frame: Baseline and Up to Day 3
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 8 hour (n=30,31,32,30) | 0.29 Degree Celsius | Standard Deviation 0.497 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 1 hour (n=30,31,32,30) | 0.06 Degree Celsius | Standard Deviation 0.275 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 12 hour (n=30,31,32,30) | 0.31 Degree Celsius | Standard Deviation 0.47 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 24 hour (n=30,31,32,30) | 0.34 Degree Celsius | Standard Deviation 0.347 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 72 hour (n=30,31,31,30) | 0.33 Degree Celsius | Standard Deviation 0.422 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 2 hour (n=29,31,32,30) | 0.05 Degree Celsius | Standard Deviation 0.341 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 0.5 hour (n=30,31,32,30) | 0.06 Degree Celsius | Standard Deviation 0.239 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 4 hour(n=30,31,32,30) | 0.10 Degree Celsius | Standard Deviation 0.371 |
| Part 1,Treatment F1 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 48 hour (n=30,31,32,30) | 0.19 Degree Celsius | Standard Deviation 0.448 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 4 hour(n=30,31,32,30) | 0.05 Degree Celsius | Standard Deviation 0.385 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 2 hour (n=29,31,32,30) | 0.07 Degree Celsius | Standard Deviation 0.33 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 24 hour (n=30,31,32,30) | 0.12 Degree Celsius | Standard Deviation 0.453 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 72 hour (n=30,31,31,30) | 0.26 Degree Celsius | Standard Deviation 0.446 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 12 hour (n=30,31,32,30) | 0.39 Degree Celsius | Standard Deviation 0.358 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 1 hour (n=30,31,32,30) | 0.07 Degree Celsius | Standard Deviation 0.29 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 48 hour (n=30,31,32,30) | 0.13 Degree Celsius | Standard Deviation 0.424 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 0.5 hour (n=30,31,32,30) | 0.13 Degree Celsius | Standard Deviation 0.329 |
| Part 1,Treatment F2 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 8 hour (n=30,31,32,30) | 0.22 Degree Celsius | Standard Deviation 0.419 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 24 hour (n=30,31,32,30) | 0.23 Degree Celsius | Standard Deviation 0.352 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 0.5 hour (n=30,31,32,30) | 0.11 Degree Celsius | Standard Deviation 0.404 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 1 hour (n=30,31,32,30) | 0.10 Degree Celsius | Standard Deviation 0.33 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 2 hour (n=29,31,32,30) | 0.09 Degree Celsius | Standard Deviation 0.316 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 4 hour(n=30,31,32,30) | 0.07 Degree Celsius | Standard Deviation 0.43 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 8 hour (n=30,31,32,30) | 0.23 Degree Celsius | Standard Deviation 0.456 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 12 hour (n=30,31,32,30) | 0.32 Degree Celsius | Standard Deviation 0.463 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 48 hour (n=30,31,32,30) | 0.16 Degree Celsius | Standard Deviation 0.456 |
| Part 1,Treatment F3 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 72 hour (n=30,31,31,30) | 0.14 Degree Celsius | Standard Deviation 0.45 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 24 hour (n=30,31,32,30) | 0.19 Degree Celsius | Standard Deviation 0.42 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 4 hour(n=30,31,32,30) | 0.09 Degree Celsius | Standard Deviation 0.275 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 2 hour (n=29,31,32,30) | 0.04 Degree Celsius | Standard Deviation 0.233 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 72 hour (n=30,31,31,30) | 0.08 Degree Celsius | Standard Deviation 0.377 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 48 hour (n=30,31,32,30) | 0.22 Degree Celsius | Standard Deviation 0.444 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 1 hour (n=30,31,32,30) | 0.09 Degree Celsius | Standard Deviation 0.291 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 0.5 hour (n=30,31,32,30) | 0.05 Degree Celsius | Standard Deviation 0.256 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 12 hour (n=30,31,32,30) | 0.45 Degree Celsius | Standard Deviation 0.425 |
| Part 1,Treatment F4 | Change From Baseline in Vital- Temperature, Part 3B | Temperature, 8 hour (n=30,31,32,30) | 0.17 Degree Celsius | Standard Deviation 0.502 |
Secondary
Number of Participants With Abnormal ECG Findings, -Part 2
12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Time frame: Up to Day 3
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Abnormal ECG Findings, -Part 2 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal ECG Findings, -Part 2 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal ECG Findings, -Part 2 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal ECG Findings, -Part 2 | 0 Participants |
Secondary
Number of Participants With Abnormal ECG Findings, -Part 3A
12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Time frame: Up to Day 3
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Abnormal ECG Findings, -Part 3A | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal ECG Findings, -Part 3A | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal ECG Findings, -Part 3A | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal ECG Findings, -Part 3A | 0 Participants |
Secondary
Number of Participants With Abnormal ECG Findings, -Part 3B
12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Time frame: Up to Day 3
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Abnormal ECG Findings, -Part 3B | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal ECG Findings, -Part 3B | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal ECG Findings, -Part 3B | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal ECG Findings, -Part 3B | 0 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1
12-lead ECG, was measured in semi-supine position after 5 minutes rest. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.
Time frame: Up to Day 3
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | 0 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.
Time frame: Up to Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, Day -1 | 2 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, 48 hour | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, 48 hour | 2 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, Day -1 | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, Day -1 | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, Day -1 | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, Day -1 | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, 48 hour | 2 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, 48 hour | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, 48 hour | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, Day -1 | 1 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 1+, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 1+, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone 1+, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, 2+, Day -1 | 1 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace, 48 hour | 1 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Glucose, trace, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-Intact, 48 hour | 3 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, trace-lysed, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Occult blood, 1+, Day -1 | 1 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1, Treatment R | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Protein, trace-Intact, Day -1 | 0 Participants |
Secondary
Number of Participants With Clinical Chemistry Values of PCI- Part1
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Calcium, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Albumin, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Glucose, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Sodium, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Potassium, high | 0 Participants |
Secondary
Number of Participants With Clinical Chemistry Values of PCI- Part 2
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Calcium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Potassium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Albumin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Glucose, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Sodium, low | 0 Participants |
Secondary
Number of Participants With Clinical Chemistry Values of PCI- Part 3A
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Calcium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Potassium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Albumin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Glucose, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Sodium, low | 0 Participants |
Secondary
Number of Participants With Clinical Chemistry Values of PCI- Part 3B
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, high | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Calcium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Potassium, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Albumin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Glucose, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Sodium, low | 0 Participants |
Secondary
Number of Participants With Hematology Values of PCI - Part 2
Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, low | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, low | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, low | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Leukocytes, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, high | 00 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Neutrophils, low | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 2 | Platelets, low | 0 Participants |
Secondary
Number of Participants With Hematology Values of PCI - Part 3A
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hours). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, low | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, low | 2 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, low | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, low | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Leukocytes, low | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Neutrophils, low | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Hematocrit, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3A | Platelets, low | 0 Participants |
Secondary
Number of Participants With Hematology Values of PCI - Part 3B
Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, low | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, low | 2 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, low | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, low | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Leukocytes, low | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Neutrophils, low | 2 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Hematocrit, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of PCI - Part 3B | Platelets, low | 0 Participants |
Secondary
Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1
Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.
Time frame: Up to Day 3
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocyte, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, low | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocyte, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, low | 2 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, low | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocytes, low | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, low | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocyte, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, low | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, low | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, high | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocyte, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocytes, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, low | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, high | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, low | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, low | 1 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocyte, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hematocrit, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, high | 1 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, high | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Lymphocytes, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Platelets, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Neutrophils, low | 1 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Hemoglobin, low | 0 Participants |
| Part 1, Treatment R | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Leukocytes, low | 1 Participants |
Secondary
Number of Participants With SAEs and AEs-Part 2
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Time frame: Up to 35 days
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With SAEs and AEs-Part 2 | Any SAE | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With SAEs and AEs-Part 2 | Any AE | 13 Participants |
| Part 1,Treatment F2 | Number of Participants With SAEs and AEs-Part 2 | Any AE | 12 Participants |
| Part 1,Treatment F2 | Number of Participants With SAEs and AEs-Part 2 | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With SAEs and AEs-Part 2 | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With SAEs and AEs-Part 2 | Any AE | 14 Participants |
| Part 1,Treatment F4 | Number of Participants With SAEs and AEs-Part 2 | Any SAE | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With SAEs and AEs-Part 2 | Any AE | 12 Participants |
Secondary
Number of Participants With SAEs and AEs-Part 3A
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Time frame: Up to 44 days
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With SAEs and AEs-Part 3A | Any AE | 24 Participants |
| Part 1,Treatment F1 | Number of Participants With SAEs and AEs-Part 3A | Any SAE | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With SAEs and AEs-Part 3A | Any AE | 21 Participants |
| Part 1,Treatment F2 | Number of Participants With SAEs and AEs-Part 3A | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With SAEs and AEs-Part 3A | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With SAEs and AEs-Part 3A | Any AE | 25 Participants |
| Part 1,Treatment F4 | Number of Participants With SAEs and AEs-Part 3A | Any AE | 23 Participants |
| Part 1,Treatment F4 | Number of Participants With SAEs and AEs-Part 3A | Any SAE | 0 Participants |
Secondary
Number of Participants With SAEs and AEs-Part 3B
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Time frame: Up to 44 days
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With SAEs and AEs-Part 3B | Any SAE | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With SAEs and AEs-Part 3B | Any AE | 20 Participants |
| Part 1,Treatment F2 | Number of Participants With SAEs and AEs-Part 3B | Any AE | 18 Participants |
| Part 1,Treatment F2 | Number of Participants With SAEs and AEs-Part 3B | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With SAEs and AEs-Part 3B | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With SAEs and AEs-Part 3B | Any AE | 24 Participants |
| Part 1,Treatment F4 | Number of Participants With SAEs and AEs-Part 3B | Any SAE | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With SAEs and AEs-Part 3B | Any AE | 15 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.
Time frame: Up to 42 days
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any SAE | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any AE | 12 Participants |
| Part 1,Treatment F2 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any SAE | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any AE | 13 Participants |
| Part 1,Treatment F3 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any SAE | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any AE | 13 Participants |
| Part 1,Treatment F4 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any AE | 15 Participants |
| Part 1,Treatment F4 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any SAE | 0 Participants |
| Part 1, Treatment R | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any SAE | 0 Participants |
| Part 1, Treatment R | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | Any AE | 12 Participants |
Secondary
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis
Time frame: Up to Day 2
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, Day -1 | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, Day -1 | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, 48 hour | 3 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, Day -1 | 2 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, Day -1 | 2 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, Day -1 | 2 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, 48 hour | 3 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, Day -1 | 2 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, 48 hour | 3 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, 48 hour | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, 48 hour | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Occult blood, 2+, 48 hour | 0 Participants |
Secondary
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.
Time frame: Up to Day 2
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, Day -1 | 4 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, 48 hour | 2 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, Day -1 | 3 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, Day -1 | 4 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, 48 hour | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, 48 hour | 3 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, Day -1 | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, 48 hour | 2 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, Day -1 | 6 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, Day -1 | 2 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, 48 hour | 5 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, Day -1 | 3 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, Day -1 | 4 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, Day -1 | 2 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, 48 hour | 2 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, 48 hour | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, 48 hour | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, Day -1 | 4 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, Day -1 | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, Day -1 | 2 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, Day -1 | 4 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace, 48 hour | 2 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace, 48 hour | 3 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 1+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 1+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, 48 hour | 2 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, trace-lysed, Day -1 | 3 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Protein, 2+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Glucose, 2+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Occult blood, 1+, 48 hour | 1 Participants |
Secondary
Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B
Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.
Time frame: Up to Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, Day -1 | 2 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, 48 hour | 2 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, 48 hour | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, Day -1 | 1 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F1 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, 48 hour | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, Day -1 | 4 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, Day -1 | 1 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F2 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, Day -1 | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, 48 hour | 1 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, Day -1 | 4 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, Day -1 | 3 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F3 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace-intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, trace, 48 hour | 2 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Ketone, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Glucose, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, Day -1 | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace-Intact, 48 hour | 1 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, trace, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Occult blood, 3+, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, Day -1 | 2 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, 3+, Day -1 | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-lysed, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace-Intact, 48 hour | 0 Participants |
| Part 1,Treatment F4 | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Protein, trace, 48 hour | 1 Participants |
Secondary
Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Ambrisentan, t1/2 | 16.74 Hour | Geometric Coefficient of Variation 18.2 |
| Part 1,Treatment F1 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Tadalafil, t1/2 | 17.08 Hour | Geometric Coefficient of Variation 30.4 |
| Part 1,Treatment F2 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Ambrisentan, t1/2 | 15.25 Hour | Geometric Coefficient of Variation 19.2 |
| Part 1,Treatment F2 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Tadalafil, t1/2 | 17.76 Hour | Geometric Coefficient of Variation 33.3 |
| Part 1,Treatment F3 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Ambrisentan, t1/2 | 15.76 Hour | Geometric Coefficient of Variation 17.3 |
| Part 1,Treatment F3 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Tadalafil, t1/2 | 18.38 Hour | Geometric Coefficient of Variation 33.3 |
| Part 1,Treatment F4 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Tadalafil, t1/2 | 18.48 Hour | Geometric Coefficient of Variation 33 |
| Part 1,Treatment F4 | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Ambrisentan, t1/2 | 15.25 Hour | Geometric Coefficient of Variation 20 |
| Part 1, Treatment R | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Ambrisentan, t1/2 | 16.08 Hour | Geometric Coefficient of Variation 17.9 |
| Part 1, Treatment R | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | Tadalafil, t1/2 | 18.04 Hour | Geometric Coefficient of Variation 30.4 |
Secondary
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Ambrisentan, t1/2 (n=21,20,20,20) | 15.19 Hour | Geometric Coefficient of Variation 24.5 |
| Part 1,Treatment F1 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Tadalafil, t1/2, (n=20,20,20,20) | 18.58 Hour | Geometric Coefficient of Variation 30.6 |
| Part 1,Treatment F2 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Tadalafil, t1/2, (n=20,20,20,20) | 18.63 Hour | Geometric Coefficient of Variation 33.2 |
| Part 1,Treatment F2 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Ambrisentan, t1/2 (n=21,20,20,20) | 15.76 Hour | Geometric Coefficient of Variation 33.3 |
| Part 1,Treatment F3 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Ambrisentan, t1/2 (n=21,20,20,20) | 15.39 Hour | Geometric Coefficient of Variation 18.6 |
| Part 1,Treatment F3 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Tadalafil, t1/2, (n=20,20,20,20) | 18.22 Hour | Geometric Coefficient of Variation 33.2 |
| Part 1,Treatment F4 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Ambrisentan, t1/2 (n=21,20,20,20) | 16.60 Hour | Geometric Coefficient of Variation 34.4 |
| Part 1,Treatment F4 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | Tadalafil, t1/2, (n=20,20,20,20) | 17.98 Hour | Geometric Coefficient of Variation 32.6 |
Secondary
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Ambrisentan, t1/2 | 15.65 Hour | Geometric Coefficient of Variation 16.7 |
| Part 1,Treatment F1 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Tadalafil, t1/2 | 20.09 Hour | Geometric Coefficient of Variation 34.4 |
| Part 1,Treatment F2 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Tadalafil, t1/2 | 19.85 Hour | Geometric Coefficient of Variation 34.2 |
| Part 1,Treatment F2 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Ambrisentan, t1/2 | 15.42 Hour | Geometric Coefficient of Variation 15.9 |
| Part 1,Treatment F3 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Ambrisentan, t1/2 | 14.66 Hour | Geometric Coefficient of Variation 13.7 |
| Part 1,Treatment F3 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Tadalafil, t1/2 | 19.29 Hour | Geometric Coefficient of Variation 33.4 |
| Part 1,Treatment F4 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Ambrisentan, t1/2 | 15.63 Hour | Geometric Coefficient of Variation 16.6 |
| Part 1,Treatment F4 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | Tadalafil, t1/2 | 19.86 Hour | Geometric Coefficient of Variation 36.8 |
Secondary
Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B
t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints.
Time frame: Pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48, and 72 hours postdose
Population: PK parameter Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1,Treatment F1 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Ambrisentan, t1/2 | 16.39 Hour | Geometric Coefficient of Variation 21.6 |
| Part 1,Treatment F1 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Tadalafil, t1/2 | 20.27 Hour | Geometric Coefficient of Variation 34.3 |
| Part 1,Treatment F2 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Tadalafil, t1/2 | 19.01 Hour | Geometric Coefficient of Variation 31.1 |
| Part 1,Treatment F2 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Ambrisentan, t1/2 | 16.42 Hour | Geometric Coefficient of Variation 17.1 |
| Part 1,Treatment F3 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Ambrisentan, t1/2 | 16.15 Hour | Geometric Coefficient of Variation 18.7 |
| Part 1,Treatment F3 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Tadalafil, t1/2 | 20.34 Hour | Geometric Coefficient of Variation 34.4 |
| Part 1,Treatment F4 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Ambrisentan, t1/2 | 16.00 Hour | Geometric Coefficient of Variation 19.7 |
| Part 1,Treatment F4 | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | Tadalafil, t1/2 | 18.95 Hour | Geometric Coefficient of Variation 30.8 |
Secondary
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1
Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Tadafil, Tmax | 1.500 Hour |
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Ambrisentan, Tmax | 1.000 Hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Ambrisentan, Tmax | 1.500 Hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Tadafil, Tmax | 2.000 Hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Ambrisentan, Tmax | 1.500 Hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Tadafil, Tmax | 2.000 Hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Ambrisentan, Tmax | 1.500 Hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Tadafil, Tmax | 2.000 Hour |
| Part 1, Treatment R | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Tadafil, Tmax | 1.500 Hour |
| Part 1, Treatment R | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Ambrisentan, Tmax | 1.500 Hour |
Secondary
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2
Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Ambrisentan, Tmax (n=21,20,20,20) | 1.500 hour |
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Tadafil, Tmax (n=20,20,20,20) | 2.017 hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Tadafil, Tmax (n=20,20,20,20) | 1.750 hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Ambrisentan, Tmax (n=21,20,20,20) | 1.500 hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Ambrisentan, Tmax (n=21,20,20,20) | 1.500 hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Tadafil, Tmax (n=20,20,20,20) | 2.000 hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Ambrisentan, Tmax (n=21,20,20,20) | 1.508 hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Tadafil, Tmax (n=20,20,20,20) | 2.000 hour |
Secondary
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A
Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Ambrisentan, Tmax | 4.00 Hour |
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Tadafil, Tmax | 8.000 Hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Tadafil, Tmax | 2.500 Hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Ambrisentan, Tmax | 1.500 Hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Ambrisentan, Tmax | 4.00 Hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Tadafil, Tmax | 8.000 Hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Ambrisentan, Tmax | 2.000 Hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Tadafil, Tmax | 2.258 Hour |
Secondary
Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B
Serial blood samples were collected at the indicated time-points. In Part 3B, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Population: PK parameter Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Ambrisentan, Tmax | 1.767 Hour |
| Part 1,Treatment F1 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Tadafil, Tmax | 2.500 Hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Tadafil, Tmax | 1.500 Hour |
| Part 1,Treatment F2 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Ambrisentan, Tmax | 1.500 Hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Ambrisentan, Tmax | 2.000 Hour |
| Part 1,Treatment F3 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Tadafil, Tmax | 2.500 Hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Ambrisentan, Tmax | 1.758 Hour |
| Part 1,Treatment F4 | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Tadafil, Tmax | 2.008 Hour |