Infections, Bacterial
Conditions
Keywords
GR37547, Cross-over, Bioequivalence, Ciprofloxacin
Brief summary
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at least 7 days and not more than 14 days. The total duration of study for each subject will be approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a single center.
Interventions
DRUGGR37547 tablet
A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed GSK500on lower side.
DRUGCiprofloxacin reference tablet
A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water. Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500 marked on upper side and BAYER on lower side.
Sponsors
Parexel
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This will be an open-label study. Hence, masking will not be performed.
Intervention model description
Crossover assignment: Subjects will receive treatment in one of the two sequences; Treatment A (GR37547 tablet) followed by Treatment B (ciprofloxacin reference tablet) or vice versa separated by a washout period of at least 7 days and not more than 14 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be between 18 and 60 years of age inclusive, at the time of signing the informed consent. * Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the normal reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required,agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight \>=50 kilogram (kg) and body mass index (BMI) within the range 19-30 kg per meter square (kg/m\^2) (inclusive). * Healthy Male or female subjects: Male subjects: A male subject must agree to use contraception during the treatment period and for at least 5 days, after the last dose of study treatment and refrain from donating sperm during this period; Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment. * The investigator is responsible for ensuring that male and female study subjects understand how to correctly use the methods of contraception. * Capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin | Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period | Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study. |
| Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin | Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period | Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin | Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period | Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. |
| Terminal Phase Half-life (t1/2) for Ciprofloxacin | Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period | Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. |
| Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs) | Up to 4 weeks in each treatment period | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received. |
| Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, Alk phos, AST and LD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Blood Urea Nitrogen (BUN) at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, chloride, glucose, magnesium, potassium and sodium. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Total Protein at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Corpuscular Volume (MCV) at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin | Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period | Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. |
| Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Percent Reticulocytes at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Hematocrit at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Erythrocyte Count at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Clinically Significant Abnormal Findings for Urinalysis | Up to Day 2 of each treatment period | Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. The number of participants with abnormal (clinically significant) findings for urinalysis have been presented. |
| Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters | Up to Day 2 of each treatment period | A single 12-lead ECGs was obtained on Day 1 and Day 2 of each treatment period 1 and 2 using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. The number of participants with abnormal (clinically significant) findings for ECG parameters have been presented. |
| Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | Up to Day 2 of each treatment period | Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Respiratory Rate at Indicated Time-points | Up to Day 2 of each treatment period | Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Pulse Rate at Indicated Time-points | Up to Day 2 of each treatment period | Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Body Temperature at Indicated Time-points | Up to Day 2 of each treatment period | Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Up to Day 2 of each treatment period | Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Time of Occurrence of Cmax (Tmax) for Ciprofloxacin | Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period | Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of ciprofloxacin was analyzed using a nonparametric test to compute point estimate of the median and full range. |
Countries
South Africa
Participant flow
Recruitment details
This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of GR37547 ciprofloxacin 500 milligrams (mg) test product versus ciprofloxacin 500 mg reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.
Pre-assignment details
Participants received treatment in one of the two sequences; Treatment A (GR37547) followed by Treatment B (ciprofloxacin reference) or vice versa in each of the treatment period 1 and 2. A total number of 26 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Eligible participants received a single dose of Treatment A (GR37547 500 mg tablet) followed by Treatment B (ciprofloxacin 500 mg reference tablet) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1 (Up to 4 Weeks) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 23.5 Years STANDARD_DEVIATION 5.62 |
| Race/Ethnicity, Customized Black or African American | 18 Participants |
| Race/Ethnicity, Customized Other-Mixed Race | 2 Participants |
| Race/Ethnicity, Customized White -White/Caucasian/European Heritage | 6 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 6 / 26 | 6 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
Time frame: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin | 11600 Hour*nanogram per milliliter | Geometric Coefficient of Variation 22.5 |
| GR37547 500 mg | Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin | 11300 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.7 |
90% CI: [91.13, 103]
Primary
Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
Time frame: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin | 3140 Nanogram per milliliter | Geometric Coefficient of Variation 21.6 |
| GR37547 500 mg | Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin | 2940 Nanogram per milliliter | Geometric Coefficient of Variation 29.6 |
90% CI: [86.09, 100.82]
Secondary
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, Alk phos, AST and LD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 17.3 Units per liter | Standard Deviation 10.5 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 15.3 Units per liter | Standard Deviation 8.74 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 21.2 Units per liter | Standard Deviation 22.95 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 20.8 Units per liter | Standard Deviation 28.51 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 1;Day -1,24 Hours Pre-dose;n=13,13 | 72.7 Units per liter | Standard Deviation 21.83 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 1;Day 2,24 Hours Post-dose;n=13,13 | 67.6 Units per liter | Standard Deviation 22.88 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 2;Day -1,24 Hours Pre-dose;n=13,12 | 63.8 Units per liter | Standard Deviation 15.66 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 2;Day 2,24 Hours Post-dose;n=13,12 | 59.4 Units per liter | Standard Deviation 13.48 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 21.3 Units per liter | Standard Deviation 6.82 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 18.2 Units per liter | Standard Deviation 4.51 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 22.6 Units per liter | Standard Deviation 8.83 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 19.4 Units per liter | Standard Deviation 7.4 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 324.9 Units per liter | Standard Deviation 57.56 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 280.6 Units per liter | Standard Deviation 47.22 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 331.4 Units per liter | Standard Deviation 49.08 |
| Ciprofloxacin 500 mg Reference | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 287.2 Units per liter | Standard Deviation 52.27 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 291.8 Units per liter | Standard Deviation 43 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 18.0 Units per liter | Standard Deviation 10.85 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 20.8 Units per liter | Standard Deviation 3.39 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 16.4 Units per liter | Standard Deviation 12.71 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 322.2 Units per liter | Standard Deviation 56.71 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 16.6 Units per liter | Standard Deviation 10.75 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 17.5 Units per liter | Standard Deviation 3.67 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | ALT; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 14.6 Units per liter | Standard Deviation 9.41 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 327.0 Units per liter | Standard Deviation 54.87 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 1;Day -1,24 Hours Pre-dose;n=13,13 | 65.5 Units per liter | Standard Deviation 15.69 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 21.2 Units per liter | Standard Deviation 8.79 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 1;Day 2,24 Hours Post-dose;n=13,13 | 61.0 Units per liter | Standard Deviation 15.02 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | LD; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 273.9 Units per liter | Standard Deviation 46 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 2;Day -1,24 Hours Pre-dose;n=13,12 | 74.9 Units per liter | Standard Deviation 22.51 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | AST; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 18.3 Units per liter | Standard Deviation 5.73 |
| GR37547 500 mg | Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points | Alk Phos;Period 2;Day 2,24 Hours Post-dose;n=13,12 | 70.3 Units per liter | Standard Deviation 23.59 |
Secondary
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
Time frame: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin | 12000 Hour*nanogram per milliliter | Geometric Coefficient of Variation 22 |
| GR37547 500 mg | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin | 11600 Hour*nanogram per milliliter | Geometric Coefficient of Variation 27.3 |
90% CI: [91.17, 103.11]
Secondary
Blood Urea Nitrogen (BUN) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 11.322 Milligrams per deciliter | Standard Deviation 3.81 |
| Ciprofloxacin 500 mg Reference | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 10.909 Milligrams per deciliter | Standard Deviation 2.611 |
| Ciprofloxacin 500 mg Reference | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 11.444 Milligrams per deciliter | Standard Deviation 3.133 |
| Ciprofloxacin 500 mg Reference | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 10.548 Milligrams per deciliter | Standard Deviation 1.674 |
| GR37547 500 mg | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 11.583 Milligrams per deciliter | Standard Deviation 1.86 |
| GR37547 500 mg | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 10.392 Milligrams per deciliter | Standard Deviation 2.201 |
| GR37547 500 mg | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 11.682 Milligrams per deciliter | Standard Deviation 2.241 |
| GR37547 500 mg | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 10.073 Milligrams per deciliter | Standard Deviation 1.51 |
Secondary
Body Temperature at Indicated Time-points
Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 1;Day 1, 1.5 Hours Pre-dose;n=13,13 | 36.43 Degree Celsius | Standard Deviation 0.455 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 1;Day 1, 2 Hours Post-dose;n=13,13 | 36.68 Degree Celsius | Standard Deviation 0.393 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 36.51 Degree Celsius | Standard Deviation 0.377 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 36.55 Degree Celsius | Standard Deviation 0.433 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 36.33 Degree Celsius | Standard Deviation 0.312 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 2;Day 1, 1.5 Hours Pre-dose;n=13,12 | 36.28 Degree Celsius | Standard Deviation 0.396 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 2;Day 1, 2 Hours Post-dose;n=13,12 | 36.62 Degree Celsius | Standard Deviation 0.361 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 36.75 Degree Celsius | Standard Deviation 0.454 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 36.62 Degree Celsius | Standard Deviation 0.392 |
| Ciprofloxacin 500 mg Reference | Body Temperature at Indicated Time-points | Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 36.38 Degree Celsius | Standard Deviation 0.458 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 36.63 Degree Celsius | Standard Deviation 0.234 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 1;Day 1, 1.5 Hours Pre-dose;n=13,13 | 36.47 Degree Celsius | Standard Deviation 0.44 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 2;Day 1, 1.5 Hours Pre-dose;n=13,12 | 36.14 Degree Celsius | Standard Deviation 0.3 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 1;Day 1, 2 Hours Post-dose;n=13,13 | 36.62 Degree Celsius | Standard Deviation 0.43 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 36.38 Degree Celsius | Standard Deviation 0.414 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 36.48 Degree Celsius | Standard Deviation 0.443 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 2;Day 1, 2 Hours Post-dose;n=13,12 | 36.17 Degree Celsius | Standard Deviation 0.334 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 36.81 Degree Celsius | Standard Deviation 0.403 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 36.75 Degree Celsius | Standard Deviation 0.48 |
| GR37547 500 mg | Body Temperature at Indicated Time-points | Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 36.38 Degree Celsius | Standard Deviation 0.363 |
Secondary
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, chloride, glucose, magnesium, potassium and sodium. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 2;Day -1,24 Hours Pre-dose;n=13,12 | 103.65 Millimoles per liter | Standard Deviation 1.975 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 2.269 Millimoles per liter | Standard Deviation 0.082 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day -1, 24 Hours Pre-dose;n=13,12 | 2.335 Millimoles per liter | Standard Deviation 0.103 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 2.265 Millimoles per liter | Standard Deviation 0.069 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 104.41 Millimoles per liter | Standard Deviation 2.077 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 1;Day 2,24 Hours Post-dose;n=13,13 | 106.29 Millimoles per liter | Standard Deviation 1.715 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day -1,24 Hours Pre-dose;n=13,13 | 2.354 Millimoles per liter | Standard Deviation 0.072 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 2;Day 2,24 Hours Post-dose;n=13,12 | 107.22 Millimoles per liter | Standard Deviation 1.213 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 1; Day -1,24 Hours Pre-dose;n=13,13 | 4.691 Millimoles per liter | Standard Deviation 0.26 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 1; Day 2,24 Hours Post-dose;n=13,13 | 4.738 Millimoles per liter | Standard Deviation 0.272 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day -1,24 Hours Pre-dose;n=13,12 | 4.377 Millimoles per liter | Standard Deviation 0.238 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day 2,24 Hours Post-dose;n=13,12 | 4.508 Millimoles per liter | Standard Deviation 0.235 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 0.830 Millimoles per liter | Standard Deviation 0.052 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 1;Day2, 24Hours Post-dose;n=13,13 | 0.813 Millimoles per liter | Standard Deviation 0.054 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 0.800 Millimoles per liter | Standard Deviation 0.055 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 2;Day 2,24Hours Post-dose;n=13,12 | 0.836 Millimoles per liter | Standard Deviation 0.048 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 4.431 Millimoles per liter | Standard Deviation 0.335 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 1;Day 2,24Hours Post-dose;n=13,13 | 4.511 Millimoles per liter | Standard Deviation 0.283 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 4.518 Millimoles per liter | Standard Deviation 0.339 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day 2,24Hours Post-dose;n=13,12 | 4.341 Millimoles per liter | Standard Deviation 0.218 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium;Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 140.15 Millimoles per liter | Standard Deviation 2.304 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium; Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 141.46 Millimoles per liter | Standard Deviation 1.506 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium;Period 2; Day -1,24 Hours Pre-dose;n=13,12 | 138.54 Millimoles per liter | Standard Deviation 1.561 |
| Ciprofloxacin 500 mg Reference | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium; Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 140.62 Millimoles per liter | Standard Deviation 1.325 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium;Period 2; Day -1,24 Hours Pre-dose;n=13,12 | 139.00 Millimoles per liter | Standard Deviation 1.809 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day -1,24 Hours Pre-dose;n=13,13 | 2.337 Millimoles per liter | Standard Deviation 0.088 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 0.823 Millimoles per liter | Standard Deviation 0.043 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 2.250 Millimoles per liter | Standard Deviation 0.081 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 4.581 Millimoles per liter | Standard Deviation 0.317 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day -1, 24 Hours Pre-dose;n=13,12 | 2.348 Millimoles per liter | Standard Deviation 0.059 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 1;Day2, 24Hours Post-dose;n=13,13 | 0.828 Millimoles per liter | Standard Deviation 0.039 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 2.309 Millimoles per liter | Standard Deviation 0.076 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium; Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 141.62 Millimoles per liter | Standard Deviation 1.502 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 104.38 Millimoles per liter | Standard Deviation 1.305 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 0.809 Millimoles per liter | Standard Deviation 0.075 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 1;Day 2,24 Hours Post-dose;n=13,13 | 106.68 Millimoles per liter | Standard Deviation 1.392 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day 2,24Hours Post-dose;n=13,12 | 4.570 Millimoles per liter | Standard Deviation 0.338 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 2;Day -1,24 Hours Pre-dose;n=13,12 | 103.74 Millimoles per liter | Standard Deviation 1.641 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Magnesium;Period 2;Day 2,24Hours Post-dose;n=13,12 | 0.841 Millimoles per liter | Standard Deviation 0.048 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Chloride;Period 2;Day 2,24 Hours Post-dose;n=13,12 | 106.68 Millimoles per liter | Standard Deviation 1.471 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium; Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 140.92 Millimoles per liter | Standard Deviation 1.443 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 1; Day -1,24 Hours Pre-dose;n=13,13 | 4.666 Millimoles per liter | Standard Deviation 0.312 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 4.450 Millimoles per liter | Standard Deviation 0.251 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 1; Day 2,24 Hours Post-dose;n=13,13 | 4.669 Millimoles per liter | Standard Deviation 0.191 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Sodium;Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 139.85 Millimoles per liter | Standard Deviation 2.478 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day -1,24 Hours Pre-dose;n=13,12 | 4.696 Millimoles per liter | Standard Deviation 0.381 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Potassium;Period 1;Day 2,24Hours Post-dose;n=13,13 | 4.349 Millimoles per liter | Standard Deviation 0.248 |
| GR37547 500 mg | Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day 2,24 Hours Post-dose;n=13,12 | 4.608 Millimoles per liter | Standard Deviation 0.255 |
Secondary
Erythrocyte Count at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Erythrocyte Count at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 4.975 10^12 cells per liter | Standard Deviation 0.415 |
| Ciprofloxacin 500 mg Reference | Erythrocyte Count at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 4.812 10^12 cells per liter | Standard Deviation 0.429 |
| Ciprofloxacin 500 mg Reference | Erythrocyte Count at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 4.804 10^12 cells per liter | Standard Deviation 0.403 |
| Ciprofloxacin 500 mg Reference | Erythrocyte Count at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 4.630 10^12 cells per liter | Standard Deviation 0.441 |
| GR37547 500 mg | Erythrocyte Count at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 4.752 10^12 cells per liter | Standard Deviation 0.454 |
| GR37547 500 mg | Erythrocyte Count at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 4.922 10^12 cells per liter | Standard Deviation 0.442 |
| GR37547 500 mg | Erythrocyte Count at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 4.918 10^12 cells per liter | Standard Deviation 0.498 |
| GR37547 500 mg | Erythrocyte Count at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 4.733 10^12 cells per liter | Standard Deviation 0.466 |
Secondary
Hematocrit at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Hematocrit at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 0.413 Proportion of red blood cells in blood | Standard Deviation 0.044 |
| Ciprofloxacin 500 mg Reference | Hematocrit at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 0.399 Proportion of red blood cells in blood | Standard Deviation 0.041 |
| Ciprofloxacin 500 mg Reference | Hematocrit at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 0.400 Proportion of red blood cells in blood | Standard Deviation 0.035 |
| Ciprofloxacin 500 mg Reference | Hematocrit at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 0.385 Proportion of red blood cells in blood | Standard Deviation 0.04 |
| GR37547 500 mg | Hematocrit at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 0.396 Proportion of red blood cells in blood | Standard Deviation 0.047 |
| GR37547 500 mg | Hematocrit at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 0.408 Proportion of red blood cells in blood | Standard Deviation 0.036 |
| GR37547 500 mg | Hematocrit at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 0.410 Proportion of red blood cells in blood | Standard Deviation 0.051 |
| GR37547 500 mg | Hematocrit at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 0.391 Proportion of red blood cells in blood | Standard Deviation 0.041 |
Secondary
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC;Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 35.00 Grams per deciliter | Standard Deviation 1.078 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC;Period 1; Day 2, 24 Hours Post-dose; n=13,13 | 35.12 Grams per deciliter | Standard Deviation 1.083 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 34.62 Grams per deciliter | Standard Deviation 0.873 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC;Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 34.78 Grams per deciliter | Standard Deviation 0.755 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 14.48 Grams per deciliter | Standard Deviation 1.862 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 14.04 Grams per deciliter | Standard Deviation 1.782 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 13.88 Grams per deciliter | Standard Deviation 1.499 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 13.41 Grams per deciliter | Standard Deviation 1.574 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 13.82 Grams per deciliter | Standard Deviation 1.985 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC;Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 34.78 Grams per deciliter | Standard Deviation 0.829 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 14.20 Grams per deciliter | Standard Deviation 1.469 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC;Period 1; Day 2, 24 Hours Post-dose; n=13,13 | 35.09 Grams per deciliter | Standard Deviation 0.852 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 14.23 Grams per deciliter | Standard Deviation 2.119 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 34.58 Grams per deciliter | Standard Deviation 1.245 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 13.74 Grams per deciliter | Standard Deviation 1.669 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC;Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 34.78 Grams per deciliter | Standard Deviation 1.176 |
Secondary
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 29.05 Picogram | Standard Deviation 2.172 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 29.13 Picogram | Standard Deviation 2.24 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 28.89 Picogram | Standard Deviation 1.87 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 28.94 Picogram | Standard Deviation 1.829 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 29.00 Picogram | Standard Deviation 2.324 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 28.86 Picogram | Standard Deviation 1.809 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 28.88 Picogram | Standard Deviation 2.316 |
| GR37547 500 mg | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 29.02 Picogram | Standard Deviation 1.94 |
Secondary
Mean Corpuscular Volume (MCV) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 82.95 Femtoliter | Standard Deviation 4.668 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 82.88 Femtoliter | Standard Deviation 4.735 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 83.42 Femtoliter | Standard Deviation 4.511 |
| Ciprofloxacin 500 mg Reference | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 83.21 Femtoliter | Standard Deviation 4.397 |
| GR37547 500 mg | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 83.27 Femtoliter | Standard Deviation 4.66 |
| GR37547 500 mg | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 83.01 Femtoliter | Standard Deviation 4.613 |
| GR37547 500 mg | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 83.30 Femtoliter | Standard Deviation 4.657 |
| GR37547 500 mg | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 82.65 Femtoliter | Standard Deviation 4.406 |
Secondary
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters
A single 12-lead ECGs was obtained on Day 1 and Day 2 of each treatment period 1 and 2 using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. The number of participants with abnormal (clinically significant) findings for ECG parameters have been presented.
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin 500 mg Reference | Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters | 0 Participants |
| GR37547 500 mg | Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormal Findings for Urinalysis
Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. The number of participants with abnormal (clinically significant) findings for urinalysis have been presented.
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin 500 mg Reference | Number of Participants With Clinically Significant Abnormal Findings for Urinalysis | 0 Participants |
| GR37547 500 mg | Number of Participants With Clinically Significant Abnormal Findings for Urinalysis | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Time frame: Up to 4 weeks in each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs) | Any Non-SAE | 6 Participants |
| Ciprofloxacin 500 mg Reference | Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs) | Any SAE | 0 Participants |
| GR37547 500 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs) | Any Non-SAE | 6 Participants |
| GR37547 500 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs) | Any SAE | 0 Participants |
Secondary
Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
Time frame: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin | 2.83 Percentage of AUCex | Geometric Coefficient of Variation 31.6 |
| GR37547 500 mg | Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin | 2.85 Percentage of AUCex | Geometric Coefficient of Variation 36.9 |
Secondary
Percent Reticulocytes at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Percent Reticulocytes at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 2.277 Percentage of reticulocytes | Standard Deviation 0.442 |
| Ciprofloxacin 500 mg Reference | Percent Reticulocytes at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 2.085 Percentage of reticulocytes | Standard Deviation 0.369 |
| Ciprofloxacin 500 mg Reference | Percent Reticulocytes at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 2.362 Percentage of reticulocytes | Standard Deviation 0.275 |
| Ciprofloxacin 500 mg Reference | Percent Reticulocytes at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 0.931 Percentage of reticulocytes | Standard Deviation 0.155 |
| GR37547 500 mg | Percent Reticulocytes at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 1.883 Percentage of reticulocytes | Standard Deviation 0.513 |
| GR37547 500 mg | Percent Reticulocytes at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 2.069 Percentage of reticulocytes | Standard Deviation 0.25 |
| GR37547 500 mg | Percent Reticulocytes at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 2.167 Percentage of reticulocytes | Standard Deviation 0.347 |
| GR37547 500 mg | Percent Reticulocytes at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 2.123 Percentage of reticulocytes | Standard Deviation 0.28 |
Secondary
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period2;Day -1,24Hours Predose;n=13,12 | 2.567 10^9 cells per liter | Standard Deviation 0.641 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period1;Day-1,24Hours Pre-dose;n=13,13 | 0.237 10^9 cells per liter | Standard Deviation 0.259 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period2;Day2,24Hours Post-dose;n=13,12 | 1.938 10^9 cells per liter | Standard Deviation 0.451 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 1;Day-1,24Hours Pre-dose;n=13,13 | 5.247 10^9 cells per liter | Standard Deviation 1.509 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 0.471 10^9 cells per liter | Standard Deviation 0.176 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period1; Day2,24Hours Post-dose ;n=13,13 | 0.031 10^9 cells per liter | Standard Deviation 0.019 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 1;Day 2,24Hours Post-dose;n=13,13 | 0.452 10^9 cells per liter | Standard Deviation 0.157 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 1;Day 2,24Hours Post-dose;n=13,13 | 4.897 10^9 cells per liter | Standard Deviation 1.232 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 0.560 10^9 cells per liter | Standard Deviation 0.167 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period1;Day2,24Hours Post-dose;n=13,13 | 0.209 10^9 cells per liter | Standard Deviation 0.186 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 2;Day 2,24Hours Post-dose;n=13,12 | 0.451 10^9 cells per liter | Standard Deviation 0.134 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 2;Day-1,24Hours Pre-dose;n=13,12 | 6.373 10^9 cells per liter | Standard Deviation 1.577 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period1;Day -1,24Hours Pre-dose;n=13,13 | 2.622 10^9 cells per liter | Standard Deviation 1.13 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period 2;Day2, 24Hours Post-dose;n=13,12 | 0.019 10^9 cells per liter | Standard Deviation 0.01 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period1;Day 2,24Hours Post-dose;n=13,13 | 2.424 10^9 cells per liter | Standard Deviation 1.393 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 2;Day 2,24Hours Post-dose;n=13,12 | 5.118 10^9 cells per liter | Standard Deviation 1.159 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period2;Day -1,24Hours Pre-dose;n=13,12 | 3.100 10^9 cells per liter | Standard Deviation 1.154 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period2;Day-1,24Hours Pre-dose;n=13,12 | 0.127 10^9 cells per liter | Standard Deviation 0.068 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period2;Day 2,24Hours Post-dose;n=13,12 | 2.594 10^9 cells per liter | Standard Deviation 0.802 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period1;Day -1,24Hours Predose;n=13,13 | 1.885 10^9 cells per liter | Standard Deviation 0.43 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 313.4 10^9 cells per liter | Standard Deviation 62.52 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 0.019 10^9 cells per liter | Standard Deviation 0.012 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 1;Day 2,24Hours Post-dose;n=13,13 | 295.1 10^9 cells per liter | Standard Deviation 63.24 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period1;Day2,24Hours Post-dose;n=13,13 | 1.781 10^9 cells per liter | Standard Deviation 0.379 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 307.6 10^9 cells per liter | Standard Deviation 70.01 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period2;Day2,24Hours Post-dose;n=13,12 | 0.115 10^9 cells per liter | Standard Deviation 0.073 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 2;Day 2,24Hours Post-dose;n=13,12 | 296.5 10^9 cells per liter | Standard Deviation 72.54 |
| Ciprofloxacin 500 mg Reference | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 0.032 10^9 cells per liter | Standard Deviation 0.02 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 2;Day 2,24Hours Post-dose;n=13,12 | 299.9 10^9 cells per liter | Standard Deviation 65.97 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 0.022 10^9 cells per liter | Standard Deviation 0.012 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period1; Day2,24Hours Post-dose ;n=13,13 | 0.018 10^9 cells per liter | Standard Deviation 0.011 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 0.033 10^9 cells per liter | Standard Deviation 0.019 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophils;Period 2;Day2, 24Hours Post-dose;n=13,12 | 0.031 10^9 cells per liter | Standard Deviation 0.021 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period1;Day-1,24Hours Pre-dose;n=13,13 | 0.132 10^9 cells per liter | Standard Deviation 0.071 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period1;Day2,24Hours Post-dose;n=13,13 | 0.128 10^9 cells per liter | Standard Deviation 0.06 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period2;Day-1,24Hours Pre-dose;n=13,12 | 0.286 10^9 cells per liter | Standard Deviation 0.259 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophils;Period2;Day2,24Hours Post-dose;n=13,12 | 0.286 10^9 cells per liter | Standard Deviation 0.271 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 1;Day-1,24Hours Pre-dose;n=13,13 | 5.915 10^9 cells per liter | Standard Deviation 1.473 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 1;Day 2,24Hours Post-dose;n=13,13 | 5.269 10^9 cells per liter | Standard Deviation 1.349 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 2;Day-1,24Hours Pre-dose;n=13,12 | 5.508 10^9 cells per liter | Standard Deviation 1.246 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte;Period 2;Day 2,24Hours Post-dose;n=13,12 | 4.973 10^9 cells per liter | Standard Deviation 0.797 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period1;Day -1,24Hours Predose;n=13,13 | 2.215 10^9 cells per liter | Standard Deviation 0.596 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period1;Day2,24Hours Post-dose;n=13,13 | 2.026 10^9 cells per liter | Standard Deviation 0.555 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period2;Day -1,24Hours Predose;n=13,12 | 2.201 10^9 cells per liter | Standard Deviation 0.47 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocytes;Period2;Day2,24Hours Post-dose;n=13,12 | 1.883 10^9 cells per liter | Standard Deviation 0.31 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 0.535 10^9 cells per liter | Standard Deviation 0.124 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 1;Day 2,24Hours Post-dose;n=13,13 | 0.495 10^9 cells per liter | Standard Deviation 0.156 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 0.519 10^9 cells per liter | Standard Deviation 0.166 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes;Period 2;Day 2,24Hours Post-dose;n=13,12 | 0.443 10^9 cells per liter | Standard Deviation 0.153 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period1;Day -1,24Hours Pre-dose;n=13,13 | 3.012 10^9 cells per liter | Standard Deviation 1.225 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period1;Day 2,24Hours Post-dose;n=13,13 | 2.602 10^9 cells per liter | Standard Deviation 1.226 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period2;Day -1,24Hours Pre-dose;n=13,12 | 2.469 10^9 cells per liter | Standard Deviation 0.774 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophil;Period2;Day 2,24Hours Post-dose;n=13,12 | 2.330 10^9 cells per liter | Standard Deviation 0.575 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 292.5 10^9 cells per liter | Standard Deviation 71.81 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 1;Day 2,24Hours Post-dose;n=13,13 | 281.5 10^9 cells per liter | Standard Deviation 62.29 |
| GR37547 500 mg | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelets;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 325.2 10^9 cells per liter | Standard Deviation 77.79 |
Secondary
Pulse Rate at Indicated Time-points
Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 1;Day 1, 1.5 Hours Pre-dose;n=13,13 | 63.2 Beats per minute | Standard Deviation 11.29 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 1;Day 1, 2 Hours Post-dose;n=13,13 | 64.2 Beats per minute | Standard Deviation 9.41 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 65.5 Beats per minute | Standard Deviation 11.3 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 72.5 Beats per minute | Standard Deviation 11.83 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 63.5 Beats per minute | Standard Deviation 9.63 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 2;Day 1, 1.5 Hours Pre-dose;n=13,12 | 67.4 Beats per minute | Standard Deviation 13 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 2;Day 1, 2 Hours Post-dose;n=13,12 | 67.0 Beats per minute | Standard Deviation 9.51 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 67.8 Beats per minute | Standard Deviation 11.26 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 76.8 Beats per minute | Standard Deviation 11.06 |
| Ciprofloxacin 500 mg Reference | Pulse Rate at Indicated Time-points | Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 67.2 Beats per minute | Standard Deviation 9.07 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 68.8 Beats per minute | Standard Deviation 10.28 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 1;Day 1, 1.5 Hours Pre-dose;n=13,13 | 69.4 Beats per minute | Standard Deviation 12.99 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 2;Day 1, 1.5 Hours Pre-dose;n=13,12 | 66.0 Beats per minute | Standard Deviation 10.26 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 1;Day 1, 2 Hours Post-dose;n=13,13 | 67.0 Beats per minute | Standard Deviation 12.17 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 66.3 Beats per minute | Standard Deviation 10.01 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 68.2 Beats per minute | Standard Deviation 12.75 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 2;Day 1, 2 Hours Post-dose;n=13,12 | 66.3 Beats per minute | Standard Deviation 11.36 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 76.6 Beats per minute | Standard Deviation 13.3 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 78.0 Beats per minute | Standard Deviation 12.17 |
| GR37547 500 mg | Pulse Rate at Indicated Time-points | Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 63.9 Beats per minute | Standard Deviation 10.67 |
Secondary
Respiratory Rate at Indicated Time-points
Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13 | 17.2 Breaths per minute | Standard Deviation 2.35 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 1;Day 1, 2 Hours Post-dose;n=13,13 | 15.1 Breaths per minute | Standard Deviation 2.53 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 17.4 Breaths per minute | Standard Deviation 1.89 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 16.6 Breaths per minute | Standard Deviation 1.26 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 16.3 Breaths per minute | Standard Deviation 3.15 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12 | 17.0 Breaths per minute | Standard Deviation 2.16 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 2;Day 1, 2 Hours Post-dose;n=13,12 | 15.0 Breaths per minute | Standard Deviation 2.45 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 15.7 Breaths per minute | Standard Deviation 2.69 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 15.8 Breaths per minute | Standard Deviation 2.51 |
| Ciprofloxacin 500 mg Reference | Respiratory Rate at Indicated Time-points | Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 16.8 Breaths per minute | Standard Deviation 1.92 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 16.8 Breaths per minute | Standard Deviation 1.59 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13 | 16.6 Breaths per minute | Standard Deviation 1.85 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12 | 16.7 Breaths per minute | Standard Deviation 1.92 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 1;Day 1, 2 Hours Post-dose;n=13,13 | 15.2 Breaths per minute | Standard Deviation 2.09 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 2;Day 2, 24 Hours Post-dose;n=13,12 | 17.2 Breaths per minute | Standard Deviation 2.48 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 16.5 Breaths per minute | Standard Deviation 2.18 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 2;Day 1, 2 Hours Post-dose;n=13,12 | 16.3 Breaths per minute | Standard Deviation 3.25 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 16.2 Breaths per minute | Standard Deviation 2.08 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 16.2 Breaths per minute | Standard Deviation 2.48 |
| GR37547 500 mg | Respiratory Rate at Indicated Time-points | Period 1;Day 2, 24 Hours Post-dose;n=13,13 | 16.6 Breaths per minute | Standard Deviation 2.63 |
Secondary
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13 | 107.2 Millimeters of mercury | Standard Deviation 9.81 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 2 Hours Post-dose;n=13,13 | 108.4 Millimeters of mercury | Standard Deviation 9.11 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 4 Hours Post-dose;n=13,13 | 109.2 Millimeters of mercury | Standard Deviation 10.49 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 6 Hours Post-dose;n=13,13 | 106.3 Millimeters of mercury | Standard Deviation 9.36 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 104.6 Millimeters of mercury | Standard Deviation 8.83 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12 | 104.0 Millimeters of mercury | Standard Deviation 5.83 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 2 Hours Post-dose;n=13,12 | 106.9 Millimeters of mercury | Standard Deviation 5.82 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 4 Hours Post-dose=13,12 | 105.0 Millimeters of mercury | Standard Deviation 7.6 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 6 Hours Post-dose=13,12 | 103.6 Millimeters of mercury | Standard Deviation 9.18 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 2, 24 Hours Post-dose=13,12 | 109.1 Millimeters of mercury | Standard Deviation 5.91 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13 | 60.5 Millimeters of mercury | Standard Deviation 8.75 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 1; Day 1, 2 Hours Post-dose;n=13,13 | 60.0 Millimeters of mercury | Standard Deviation 5.76 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 60.2 Millimeters of mercury | Standard Deviation 6.89 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 56.2 Millimeters of mercury | Standard Deviation 6.38 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 59.1 Millimeters of mercury | Standard Deviation 4.92 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12 | 60.7 Millimeters of mercury | Standard Deviation 6.14 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 2; Day 1, 2 Hours Post-dose;n=13,12 | 60.8 Millimeters of mercury | Standard Deviation 3.87 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 57.7 Millimeters of mercury | Standard Deviation 5.63 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 55.2 Millimeters of mercury | Standard Deviation 3.39 |
| Ciprofloxacin 500 mg Reference | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 64.5 Millimeters of mercury | Standard Deviation 5.98 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 2;Day 1, 4 Hours Post-dose;n=13,12 | 60.9 Millimeters of mercury | Standard Deviation 4.96 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13 | 109.8 Millimeters of mercury | Standard Deviation 9.25 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13 | 62.6 Millimeters of mercury | Standard Deviation 7.46 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 2 Hours Post-dose;n=13,13 | 106.3 Millimeters of mercury | Standard Deviation 9.68 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12 | 60.0 Millimeters of mercury | Standard Deviation 4 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 4 Hours Post-dose;n=13,13 | 108.8 Millimeters of mercury | Standard Deviation 7.22 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 1; Day 1, 2 Hours Post-dose;n=13,13 | 61.2 Millimeters of mercury | Standard Deviation 7.18 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 1, 6 Hours Post-dose;n=13,13 | 104.1 Millimeters of mercury | Standard Deviation 7.76 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 60.8 Millimeters of mercury | Standard Deviation 4.53 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 105.5 Millimeters of mercury | Standard Deviation 6.29 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 1;Day 1, 4 Hours Post-dose;n=13,13 | 59.8 Millimeters of mercury | Standard Deviation 5.64 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12 | 105.8 Millimeters of mercury | Standard Deviation 4.83 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP;Period 2; Day 1, 2 Hours Post-dose;n=13,12 | 59.7 Millimeters of mercury | Standard Deviation 6.69 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 2 Hours Post-dose;n=13,12 | 104.9 Millimeters of mercury | Standard Deviation 9.67 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 1;Day 1, 6 Hours Post-dose;n=13,13 | 56.5 Millimeters of mercury | Standard Deviation 3.62 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 4 Hours Post-dose=13,12 | 108.9 Millimeters of mercury | Standard Deviation 8.02 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 2;Day 1, 6 Hours Post-dose;n=13,12 | 56.5 Millimeters of mercury | Standard Deviation 3.92 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 1, 6 Hours Post-dose=13,12 | 107.8 Millimeters of mercury | Standard Deviation 7.56 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 60.5 Millimeters of mercury | Standard Deviation 6.81 |
| GR37547 500 mg | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP;Period 2; Day 2, 24 Hours Post-dose=13,12 | 107.5 Millimeters of mercury | Standard Deviation 6.88 |
Secondary
Terminal Phase Half-life (t1/2) for Ciprofloxacin
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
Time frame: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Terminal Phase Half-life (t1/2) for Ciprofloxacin | 5.02 Hours | Geometric Coefficient of Variation 13.5 |
| GR37547 500 mg | Terminal Phase Half-life (t1/2) for Ciprofloxacin | 4.82 Hours | Geometric Coefficient of Variation 19.8 |
Secondary
Time of Occurrence of Cmax (Tmax) for Ciprofloxacin
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of ciprofloxacin was analyzed using a nonparametric test to compute point estimate of the median and full range.
Time frame: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ciprofloxacin 500 mg Reference | Time of Occurrence of Cmax (Tmax) for Ciprofloxacin | 1.253 Hours |
| GR37547 500 mg | Time of Occurrence of Cmax (Tmax) for Ciprofloxacin | 1.009 Hours |
p-value: 0.3499Wilcoxon signed-rank test
Secondary
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 9.39 Moles per liter | Standard Deviation 2.415 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 1;Day 2,24Hours Post-dose;n=13,13 | 8.18 Moles per liter | Standard Deviation 3.176 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 9.29 Moles per liter | Standard Deviation 5.012 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 2;Day 2,24Hours Post-dose;n=13,12 | 8.10 Moles per liter | Standard Deviation 4.383 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period 1;Day-1,24Hours Pre-dose;n=13,13 | 3.89 Moles per liter | Standard Deviation 0.779 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period 1;Day2,24Hours Post-dose;n=13,13 | 3.14 Moles per liter | Standard Deviation 0.965 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period2;Day-1,24Hours Pre-dose;n=13,12 | 3.50 Moles per liter | Standard Deviation 1.477 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period2;Day 2,24Hours Post-dose;n=13,12 | 3.12 Moles per liter | Standard Deviation 1.336 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 76.3 Moles per liter | Standard Deviation 11.24 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 79.2 Moles per liter | Standard Deviation 12.33 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 71.6 Moles per liter | Standard Deviation 15.61 |
| Ciprofloxacin 500 mg Reference | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 73.4 Moles per liter | Standard Deviation 17.16 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 2; Day -1, 24 Hours Pre-dose;n=13,12 | 74.8 Moles per liter | Standard Deviation 13.13 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 1;Day -1,24Hours Pre-dose;n=13,13 | 9.05 Moles per liter | Standard Deviation 5.429 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period2;Day-1,24Hours Pre-dose;n=13,12 | 3.40 Moles per liter | Standard Deviation 1.285 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 1;Day 2,24Hours Post-dose;n=13,13 | 7.88 Moles per liter | Standard Deviation 4.556 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 75.2 Moles per liter | Standard Deviation 18.15 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 2;Day -1,24Hours Pre-dose;n=13,12 | 8.78 Moles per liter | Standard Deviation 4.888 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period2;Day 2,24Hours Post-dose;n=13,12 | 2.90 Moles per liter | Standard Deviation 0.932 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil;Period 2;Day 2,24Hours Post-dose;n=13,12 | 6.90 Moles per liter | Standard Deviation 3.207 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat Period 2; Day 2, 24 Hours Post-dose;n=13,12 | 76.8 Moles per liter | Standard Deviation 12.62 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period 1;Day-1,24Hours Pre-dose;n=13,13 | 3.46 Moles per liter | Standard Deviation 1.693 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 72.2 Moles per liter | Standard Deviation 17.22 |
| GR37547 500 mg | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil;Period 1;Day2,24Hours Post-dose;n=13,13 | 2.87 Moles per liter | Standard Deviation 1.297 |
Secondary
Total Protein at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to Day 2 of each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciprofloxacin 500 mg Reference | Total Protein at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 75.45 Grams per liter | Standard Deviation 5.09 |
| Ciprofloxacin 500 mg Reference | Total Protein at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 70.32 Grams per liter | Standard Deviation 5.023 |
| Ciprofloxacin 500 mg Reference | Total Protein at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose ;n=13,12 | 73.31 Grams per liter | Standard Deviation 4.296 |
| Ciprofloxacin 500 mg Reference | Total Protein at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose ;n=13,12 | 70.23 Grams per liter | Standard Deviation 2.985 |
| GR37547 500 mg | Total Protein at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose ;n=13,12 | 72.06 Grams per liter | Standard Deviation 2.831 |
| GR37547 500 mg | Total Protein at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose;n=13,13 | 74.58 Grams per liter | Standard Deviation 3.093 |
| GR37547 500 mg | Total Protein at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose ;n=13,12 | 76.51 Grams per liter | Standard Deviation 4.268 |
| GR37547 500 mg | Total Protein at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose;n=13,13 | 68.82 Grams per liter | Standard Deviation 4.013 |