Infections, Bacterial
Conditions
Keywords
Single dose, Oral suspension, Bioequivalence, Cefixime, Two-way crossover
Brief summary
This study is open-label, randomized two-way cross-over study to determine if cefixime 200 mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200 mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult subjects under fasting conditions. There will be two treatment periods and each subject will participate in both periods. The washout period between both treatment periods will be 7-14 days. Subjects will be randomized to either of treatment sequences of reference followed by test or test followed by reference to receive a single dose of test or reference formulation on Day 1 in each treatment period. The study will last for 5 to 7 weeks.
Interventions
DRUGTest formulation A
Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.
DRUGReference formulation B
Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Subject must be 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 at investigator discretion 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. * Subject with a body weight 50 kilogram (kg) and body mass index (BMI) within the range 19-30 kilogram per meter square (kg/m\^2) (inclusive). * A healthy 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. * A female subject is eligible to participate if she is not pregnant, not breastfeeding, 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. * A subject should be capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of 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 cefixime under fasted state. Pharmacokinetic analysis of cefixime 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) Within a Participant Across All Treatments of Cefixime | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of 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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of 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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. |
| Terminal Phase Half-life (T1/2) for Cefixime | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of 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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. |
| Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Day 16 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 (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | Day -1 and 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, ALP and AST. |
| Blood Urea Nitrogen (BUN) at Indicated Time-points | Day -1 and 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. |
| Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Day -1 and 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, glucose, potassium and sodium. |
| Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Day -1 and 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. |
| Total Protein at Indicated Time-points | Day -1 and 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. |
| Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Day -1 and 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. |
| Mean Corpuscular Volume (MCV) at Indicated Time-points | Day -1 and 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. |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of 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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. |
| Erythrocyte Count at Indicated Time-points | Day -1 and 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. |
| Hematocrit at Indicated Time-points | Day -1 and 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. |
| Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Day -1 and 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. |
| Percent Reticulocytes at Indicated Time-points | Day -1 and 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. |
| Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis | Day -1 and 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. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field. |
| Respiratory Rate at Indicated Time-points | Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours 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. |
| Pulse Rate at Indicated Time-points | Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours 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. |
| Body Temperature at Indicated Time-points | Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours 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. |
| Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours 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. |
| Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Day -1 and 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. |
| Time of Occurrence of Cmax (Tmax) for Cefixime | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of 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 cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime 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 SKF101804 Cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus Cefixime 200 mg/5 mL suspension 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; SKF101804 cefixime 200mg/5mL suspension (Test formulation) followed by cefixime 200mg/5mL suspension (Reference formulation)or vice versa in each of the treatment period 1 and 2. A total number of 28 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Eligible participants received a single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) followed by Reference formulation (cefixime 200 mg/5 mL suspension) 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 28.9 Years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Black or African American | 21 Participants |
| Race/Ethnicity, Customized Mixed Race | 3 Participants |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 4 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime
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 cefixime under fasted state. Pharmacokinetic analysis of cefixime 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, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SKF101804 Cefixime | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime | 20000 Hour*nanogram per milliliter | Geometric Coefficient of Variation 32.9 |
| Cefixime Reference Formulation | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime | 19000 Hour*nanogram per milliliter | Geometric Coefficient of Variation 34.3 |
90% CI: [96.11, 115.54]
Primary
Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime
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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SKF101804 Cefixime | Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime | 2670 Nanogram per milliliter | Geometric Coefficient of Variation 29.4 |
| Cefixime Reference Formulation | Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime | 2640 Nanogram per milliliter | Geometric Coefficient of Variation 30.5 |
90% CI: [93.37, 109.55]
Secondary
Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) 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, ALP and AST.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 1; Day -1, 24 Hours Pre-dose | 16.6 Units per liter | Standard Deviation 10.23 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 1; Day 2, 24 Hours Post-dose | 13.6 Units per liter | Standard Deviation 7.09 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 2; Day -1, 24 Hours Pre-dose | 16.4 Units per liter | Standard Deviation 8.98 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 2; Day 2, 24 Hours Post-dose | 14.1 Units per liter | Standard Deviation 7.07 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 1; Day -1, 24 Hours Pre-dose | 80.4 Units per liter | Standard Deviation 12.85 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 1; Day 2, 24 Hours Post-dose | 75.5 Units per liter | Standard Deviation 14.27 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 2; Day -1, 24 Hours Pre-dose | 72.4 Units per liter | Standard Deviation 17.58 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 2; Day 2, 24 Hours Post-dose | 69.7 Units per liter | Standard Deviation 16.96 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 1; Day -1, 24 Hours Pre-dose | 20.9 Units per liter | Standard Deviation 4.4 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 1; Day 2, 24 Hours Post-dose | 16.7 Units per liter | Standard Deviation 2.64 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 2; Day -1, 24 Hours Pre-dose | 20.5 Units per liter | Standard Deviation 6 |
| SKF101804 Cefixime | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 2; Day 2, 24 Hours Post-dose | 16.8 Units per liter | Standard Deviation 3.75 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 2; Day -1, 24 Hours Pre-dose | 19.9 Units per liter | Standard Deviation 4.57 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 1; Day -1, 24 Hours Pre-dose | 15.6 Units per liter | Standard Deviation 5.67 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 2; Day -1, 24 Hours Pre-dose | 80.9 Units per liter | Standard Deviation 15.81 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 1; Day 2, 24 Hours Post-dose | 14.0 Units per liter | Standard Deviation 5.76 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 1; Day 2, 24 Hours Post-dose | 17.1 Units per liter | Standard Deviation 3.45 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 2; Day -1, 24 Hours Pre-dose | 16.7 Units per liter | Standard Deviation 9.15 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 2; Day 2, 24 Hours Post-dose | 76.9 Units per liter | Standard Deviation 15.13 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALT; Period 2; Day 2, 24 Hours Post-dose | 14.9 Units per liter | Standard Deviation 7.68 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 2; Day 2, 24 Hours Post-dose | 17.8 Units per liter | Standard Deviation 4.08 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 1; Day -1, 24 Hours Pre-dose | 74.8 Units per liter | Standard Deviation 18.25 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | AST; Period 1; Day -1, 24 Hours Pre-dose | 20.6 Units per liter | Standard Deviation 4.22 |
| Cefixime Reference Formulation | Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points | ALP; Period 1; Day 2, 24 Hours Post-dose | 67.1 Units per liter | Standard Deviation 15.23 |
Secondary
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime
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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SKF101804 Cefixime | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime | 20700 Hour*nanogram per milliliter | Geometric Coefficient of Variation 31.8 |
| Cefixime Reference Formulation | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime | 19700 Hour*nanogram per milliliter | Geometric Coefficient of Variation 33.3 |
90% CI: [96.31, 114.78]
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 10.354 Milligrams per deciliter | Standard Deviation 1.972 |
| SKF101804 Cefixime | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 12.945 Milligrams per deciliter | Standard Deviation 2.349 |
| SKF101804 Cefixime | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 10.841 Milligrams per deciliter | Standard Deviation 3.571 |
| SKF101804 Cefixime | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 12.041 Milligrams per deciliter | Standard Deviation 2.166 |
| Cefixime Reference Formulation | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 12.796 Milligrams per deciliter | Standard Deviation 1.599 |
| Cefixime Reference Formulation | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 10.300 Milligrams per deciliter | Standard Deviation 4.12 |
| Cefixime Reference Formulation | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 11.844 Milligrams per deciliter | Standard Deviation 2.017 |
| Cefixime Reference Formulation | Blood Urea Nitrogen (BUN) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 12.258 Milligrams per deciliter | Standard Deviation 2.664 |
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.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 1; Day 1, 4 Hours Post-dose | 36.48 Degree Celsius | Standard Deviation 0.336 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 36.30 Degree Celsius | Standard Deviation 0.321 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose | 36.19 Degree Celsius | Standard Deviation 0.305 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 1; Day 1, 2 Hours Post-dose | 36.38 Degree Celsius | Standard Deviation 0.333 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 1; Day 1, 6 Hours Post-dose | 36.64 Degree Celsius | Standard Deviation 0.303 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 36.29 Degree Celsius | Standard Deviation 0.317 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose | 36.28 Degree Celsius | Standard Deviation 0.372 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 2; Day 1, 2 Hours Post-dose | 36.51 Degree Celsius | Standard Deviation 0.4 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 2; Day 1, 4 Hours Post-dose | 36.58 Degree Celsius | Standard Deviation 0.347 |
| SKF101804 Cefixime | Body Temperature at Indicated Time-points | Period 2; Day 1, 6 Hours Post-dose | 36.10 Degree Celsius | Standard Deviation 0.421 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 2; Day 1, 2 Hours Post-dose | 36.42 Degree Celsius | Standard Deviation 0.404 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 1; Day 1, 4 Hours Post-dose | 36.59 Degree Celsius | Standard Deviation 0.352 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 36.24 Degree Celsius | Standard Deviation 0.365 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 36.11 Degree Celsius | Standard Deviation 0.434 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 2; Day 1, 6 Hours Post-dose | 36.63 Degree Celsius | Standard Deviation 0.3 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose | 36.27 Degree Celsius | Standard Deviation 0.336 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose | 36.29 Degree Celsius | Standard Deviation 0.317 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 1; Day 1, 2 Hours Post-dose | 36.23 Degree Celsius | Standard Deviation 0.261 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 2; Day 1, 4 Hours Post-dose | 36.51 Degree Celsius | Standard Deviation 0.243 |
| Cefixime Reference Formulation | Body Temperature at Indicated Time-points | Period 1; Day 1, 6 Hours Post-dose | 36.79 Degree Celsius | Standard Deviation 0.202 |
Secondary
Calcium, Glucose, 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, glucose, potassium and sodium.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 2;Day -1, 24 Hours Pre-dose | 141.21 Millimoles per liter | Standard Deviation 1.251 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 2;Day 2, 24 Hours Post-dose | 139.43 Millimoles per liter | Standard Deviation 1.089 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period1;Day -1, 24 Hours Pre-dose | 4.634 Millimoles per liter | Standard Deviation 0.457 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period1;Day 2, 24 Hours Post-dose | 4.522 Millimoles per liter | Standard Deviation 0.444 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day -1, 24 Hours Pre-dose | 4.371 Millimoles per liter | Standard Deviation 0.22 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day 2, 24 Hours Post-dose | 4.269 Millimoles per liter | Standard Deviation 0.334 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day -1, 24 Hours Pre-dose | 2.393 Millimoles per liter | Standard Deviation 0.059 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day 2, 24 Hours Post-dose | 2.308 Millimoles per liter | Standard Deviation 0.068 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day -1, 24 Hours Pre-dose | 2.364 Millimoles per liter | Standard Deviation 0.099 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day 2, 24 Hours Post-dose | 2.351 Millimoles per liter | Standard Deviation 0.087 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 1;Day -1, 24 Hours Pre-dose | 4.684 Millimoles per liter | Standard Deviation 0.256 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 1;Day 2, 24 Hours Post-dose | 4.728 Millimoles per liter | Standard Deviation 0.229 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day -1, 24 Hours Pre-dose | 4.521 Millimoles per liter | Standard Deviation 0.347 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day 2, 24 Hours Post-dose | 4.851 Millimoles per liter | Standard Deviation 0.375 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 1;Day -1, 24 Hours Pre-dose | 143.86 Millimoles per liter | Standard Deviation 1.46 |
| SKF101804 Cefixime | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 1;Day 2, 24 Hours Post-dose | 141.07 Millimoles per liter | Standard Deviation 1.439 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 1;Day 2, 24 Hours Post-dose | 141.43 Millimoles per liter | Standard Deviation 1.604 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 2;Day -1, 24 Hours Pre-dose | 141.50 Millimoles per liter | Standard Deviation 1.912 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day -1, 24 Hours Pre-dose | 2.376 Millimoles per liter | Standard Deviation 0.06 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 2;Day 2, 24 Hours Post-dose | 139.64 Millimoles per liter | Standard Deviation 1.55 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day -1, 24 Hours Pre-dose | 4.571 Millimoles per liter | Standard Deviation 0.404 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period1;Day -1, 24 Hours Pre-dose | 4.404 Millimoles per liter | Standard Deviation 0.316 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 2;Day 2, 24 Hours Post-dose | 2.378 Millimoles per liter | Standard Deviation 0.081 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period1;Day 2, 24 Hours Post-dose | 4.286 Millimoles per liter | Standard Deviation 0.206 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Sodium;Period 1;Day -1, 24 Hours Pre-dose | 145.00 Millimoles per liter | Standard Deviation 1.414 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day -1, 24 Hours Pre-dose | 4.521 Millimoles per liter | Standard Deviation 0.346 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 1;Day -1, 24 Hours Pre-dose | 4.616 Millimoles per liter | Standard Deviation 0.267 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Potassium;Period 2;Day 2, 24 Hours Post-dose | 4.555 Millimoles per liter | Standard Deviation 0.402 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 2;Day 2, 24 Hours Post-dose | 4.812 Millimoles per liter | Standard Deviation 0.278 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day -1, 24 Hours Pre-dose | 2.399 Millimoles per liter | Standard Deviation 0.134 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Glucose;Period 1;Day 2, 24 Hours Post-dose | 4.676 Millimoles per liter | Standard Deviation 0.295 |
| Cefixime Reference Formulation | Calcium, Glucose, Potassium and Sodium at Indicated Time-points | Calcium;Period 1;Day 2, 24 Hours Post-dose | 2.304 Millimoles per liter | Standard Deviation 0.076 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Erythrocyte Count at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 4.952 10^12 cells per liter | Standard Deviation 0.387 |
| SKF101804 Cefixime | Erythrocyte Count at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 5.104 10^12 cells per liter | Standard Deviation 0.451 |
| SKF101804 Cefixime | Erythrocyte Count at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 4.838 10^12 cells per liter | Standard Deviation 0.433 |
| SKF101804 Cefixime | Erythrocyte Count at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 5.006 10^12 cells per liter | Standard Deviation 0.366 |
| Cefixime Reference Formulation | Erythrocyte Count at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 4.906 10^12 cells per liter | Standard Deviation 0.494 |
| Cefixime Reference Formulation | Erythrocyte Count at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 5.020 10^12 cells per liter | Standard Deviation 0.48 |
| Cefixime Reference Formulation | Erythrocyte Count at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 4.971 10^12 cells per liter | Standard Deviation 0.473 |
| Cefixime Reference Formulation | Erythrocyte Count at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 4.871 10^12 cells per liter | Standard Deviation 0.424 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Hematocrit at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 0.437 Proportion of red blood cells in blood | Standard Deviation 0.036 |
| SKF101804 Cefixime | Hematocrit at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 0.422 Proportion of red blood cells in blood | Standard Deviation 0.033 |
| SKF101804 Cefixime | Hematocrit at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 0.424 Proportion of red blood cells in blood | Standard Deviation 0.029 |
| SKF101804 Cefixime | Hematocrit at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 0.408 Proportion of red blood cells in blood | Standard Deviation 0.036 |
| Cefixime Reference Formulation | Hematocrit at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 0.419 Proportion of red blood cells in blood | Standard Deviation 0.041 |
| Cefixime Reference Formulation | Hematocrit at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 0.426 Proportion of red blood cells in blood | Standard Deviation 0.043 |
| Cefixime Reference Formulation | Hematocrit at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 0.427 Proportion of red blood cells in blood | Standard Deviation 0.04 |
| Cefixime Reference Formulation | Hematocrit at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 0.411 Proportion of red blood cells in blood | Standard Deviation 0.038 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 1; Day -1, 24 Hours Pre-dose | 34.52 Grams per deciliter | Standard Deviation 1.03 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 1; Day 2, 24 Hours Post-dose | 34.88 Grams per deciliter | Standard Deviation 1.084 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 2; Day -1, 24 Hours Pre-dose | 34.64 Grams per deciliter | Standard Deviation 1.1 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 2; Day 2, 24 Hours Post-dose | 34.95 Grams per deciliter | Standard Deviation 1.097 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1;Day -1, 24 Hours Pre-dose | 15.11 Grams per deciliter | Standard Deviation 1.554 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1;Day 2, 24 Hours Post-dose | 14.74 Grams per deciliter | Standard Deviation 1.391 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2;Day -1, 24 Hours Pre-dose | 14.70 Grams per deciliter | Standard Deviation 1.381 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2;Day 2, 24 Hours Post-dose | 14.29 Grams per deciliter | Standard Deviation 1.578 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2;Day 2, 24 Hours Post-dose | 14.60 Grams per deciliter | Standard Deviation 1.708 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 1; Day -1, 24 Hours Pre-dose | 34.68 Grams per deciliter | Standard Deviation 0.957 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1;Day -1, 24 Hours Pre-dose | 14.79 Grams per deciliter | Standard Deviation 1.833 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 1; Day 2, 24 Hours Post-dose | 34.89 Grams per deciliter | Standard Deviation 1.1 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 2;Day -1, 24 Hours Pre-dose | 14.76 Grams per deciliter | Standard Deviation 1.591 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 2; Day -1, 24 Hours Pre-dose | 34.54 Grams per deciliter | Standard Deviation 0.88 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | Hb; Period 1;Day 2, 24 Hours Post-dose | 14.38 Grams per deciliter | Standard Deviation 1.623 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points | MCHC; Period 2; Day 2, 24 Hours Post-dose | 34.82 Grams per deciliter | Standard Deviation 1.062 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 29.58 Picogram | Standard Deviation 1.212 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 29.75 Picogram | Standard Deviation 1.295 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 29.40 Picogram | Standard Deviation 2.242 |
| SKF101804 Cefixime | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 29.54 Picogram | Standard Deviation 2.112 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 29.75 Picogram | Standard Deviation 1.32 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 29.44 Picogram | Standard Deviation 2.14 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 29.68 Picogram | Standard Deviation 1.207 |
| Cefixime Reference Formulation | Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 29.51 Picogram | Standard Deviation 2.19 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 85.73 Femtoliter | Standard Deviation 2.834 |
| SKF101804 Cefixime | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 85.30 Femtoliter | Standard Deviation 2.796 |
| SKF101804 Cefixime | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 84.83 Femtoliter | Standard Deviation 4.975 |
| SKF101804 Cefixime | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 84.46 Femtoliter | Standard Deviation 4.878 |
| Cefixime Reference Formulation | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 85.41 Femtoliter | Standard Deviation 2.847 |
| Cefixime Reference Formulation | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 84.86 Femtoliter | Standard Deviation 4.946 |
| Cefixime Reference Formulation | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 85.97 Femtoliter | Standard Deviation 2.903 |
| Cefixime Reference Formulation | Mean Corpuscular Volume (MCV) at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 84.50 Femtoliter | Standard Deviation 4.895 |
Secondary
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
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 Day 16 in each treatment period
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SKF101804 Cefixime | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-serious AEs | 0 Participants |
| SKF101804 Cefixime | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
| Cefixime Reference Formulation | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-serious AEs | 0 Participants |
| Cefixime Reference Formulation | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
Secondary
Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis
Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SKF101804 Cefixime | Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis | 0 Participants |
| Cefixime Reference Formulation | Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis | 0 Participants |
Secondary
Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime
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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SKF101804 Cefixime | Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime | 3.24 Percentage of AUCex | Geometric Coefficient of Variation 51.4 |
| Cefixime Reference Formulation | Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime | 3.32 Percentage of AUCex | Geometric Coefficient of Variation 67.8 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Percent Reticulocytes at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 1.786 Percentage of reticulocytes | Standard Deviation 0.361 |
| SKF101804 Cefixime | Percent Reticulocytes at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 1.757 Percentage of reticulocytes | Standard Deviation 0.384 |
| SKF101804 Cefixime | Percent Reticulocytes at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 1.729 Percentage of reticulocytes | Standard Deviation 0.397 |
| SKF101804 Cefixime | Percent Reticulocytes at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 2.350 Percentage of reticulocytes | Standard Deviation 2.176 |
| Cefixime Reference Formulation | Percent Reticulocytes at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 1.743 Percentage of reticulocytes | Standard Deviation 0.361 |
| Cefixime Reference Formulation | Percent Reticulocytes at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 1.700 Percentage of reticulocytes | Standard Deviation 0.346 |
| Cefixime Reference Formulation | Percent Reticulocytes at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 1.886 Percentage of reticulocytes | Standard Deviation 0.335 |
| Cefixime Reference Formulation | Percent Reticulocytes at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 1.571 Percentage of reticulocytes | Standard Deviation 0.297 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 2;Day -1,24 Hours Pre-dose | 2.328 10^9 cells per liter | Standard Deviation 0.573 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 1;Day-1, 24 Hours Pre-dose | 0.136 10^9 cells per liter | Standard Deviation 0.13 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 2;Day 2,24 Hours Post-dose | 2.186 10^9 cells per liter | Standard Deviation 0.431 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 1;Day-1,24 Hours Pre-dose | 5.458 10^9 cells per liter | Standard Deviation 1.643 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 1;Day -1,24 Hours Pre-dose | 0.480 10^9 cells per liter | Standard Deviation 0.123 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 1;Day -1, 24 Hours Pre-dose | 0.023 10^9 cells per liter | Standard Deviation 0.017 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 1;Day 2,24 Hours Post-dose | 0.464 10^9 cells per liter | Standard Deviation 0.142 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 1;Day 2,24 Hours Post-dose | 5.369 10^9 cells per liter | Standard Deviation 1.535 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 2;Day -1,24 Hours Pre-dose | 0.461 10^9 cells per liter | Standard Deviation 0.146 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 1;Day 2, 24 Hours Post-dose | 0.146 10^9 cells per liter | Standard Deviation 0.13 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 2;Day 2,24 Hours Post-dose | 0.475 10^9 cells per liter | Standard Deviation 0.16 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 2;Day -1,24 Hours Pre-dose | 5.736 10^9 cells per liter | Standard Deviation 1.168 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 1;Day -1,24 Hours Pre-dose | 2.692 10^9 cells per liter | Standard Deviation 1.293 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 2;Day 2, 24 Hours Post-dose | 0.024 10^9 cells per liter | Standard Deviation 0.012 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 1;Day 2,24 Hours Post-dose | 2.820 10^9 cells per liter | Standard Deviation 1.289 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 2;Day 2,24 Hours Post-dose | 5.887 10^9 cells per liter | Standard Deviation 1.216 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 2;Day -1,24 Hours Pre-dose | 2.691 10^9 cells per liter | Standard Deviation 0.697 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 2; Day -1, 24 Hours Pre-dose | 0.231 10^9 cells per liter | Standard Deviation 0.23 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 2;Day 2,24 Hours Post-dose | 2.949 10^9 cells per liter | Standard Deviation 0.848 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 1;Day -1,24 Hours Pre-dose | 2.127 10^9 cells per liter | Standard Deviation 0.562 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 1;Day -1,24 Hours Pre-dose | 288.9 10^9 cells per liter | Standard Deviation 61.98 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 1;Day 2, 24 Hours Post-dose | 0.024 10^9 cells per liter | Standard Deviation 0.012 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 1;Day 2,24 Hours Post-dose | 281.2 10^9 cells per liter | Standard Deviation 65.74 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 1;Day 2,24 Hours Post-dose | 1.916 10^9 cells per liter | Standard Deviation 0.453 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 2;Day -1,24 Hours Pre-dose | 264.6 10^9 cells per liter | Standard Deviation 61.65 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 2; Day 2, 24 Hours Post-dose | 0.253 10^9 cells per liter | Standard Deviation 0.245 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 2;Day 2,24 Hours Post-dose | 245.0 10^9 cells per liter | Standard Deviation 56.04 |
| SKF101804 Cefixime | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 2;Day -1, 24 Hours Pre-dose | 0.026 10^9 cells per liter | Standard Deviation 0.012 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 2;Day 2,24 Hours Post-dose | 274.2 10^9 cells per liter | Standard Deviation 68.61 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 2;Day -1, 24 Hours Pre-dose | 0.029 10^9 cells per liter | Standard Deviation 0.025 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 1;Day -1, 24 Hours Pre-dose | 0.022 10^9 cells per liter | Standard Deviation 0.013 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 1;Day 2, 24 Hours Post-dose | 0.025 10^9 cells per liter | Standard Deviation 0.011 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Basophil; Period 2;Day 2, 24 Hours Post-dose | 0.022 10^9 cells per liter | Standard Deviation 0.026 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 1;Day-1, 24 Hours Pre-dose | 0.182 10^9 cells per liter | Standard Deviation 0.157 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 1;Day 2, 24 Hours Post-dose | 0.204 10^9 cells per liter | Standard Deviation 0.199 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 2; Day -1, 24 Hours Pre-dose | 0.139 10^9 cells per liter | Standard Deviation 0.144 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Eosinophil; Period 2; Day 2, 24 Hours Post-dose | 0.156 10^9 cells per liter | Standard Deviation 0.182 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 1;Day-1,24 Hours Pre-dose | 5.752 10^9 cells per liter | Standard Deviation 0.907 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 1;Day 2,24 Hours Post-dose | 5.394 10^9 cells per liter | Standard Deviation 1.019 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 2;Day -1,24 Hours Pre-dose | 5.463 10^9 cells per liter | Standard Deviation 1.388 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Leucocyte; Period 2;Day 2,24 Hours Post-dose | 5.477 10^9 cells per liter | Standard Deviation 1.571 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 1;Day -1,24 Hours Pre-dose | 2.154 10^9 cells per liter | Standard Deviation 0.493 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 1;Day 2,24 Hours Post-dose | 2.039 10^9 cells per liter | Standard Deviation 0.459 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 2;Day -1,24 Hours Pre-dose | 2.141 10^9 cells per liter | Standard Deviation 0.409 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Lymphocyte; Period 2;Day 2,24 Hours Post-dose | 1.956 10^9 cells per liter | Standard Deviation 0.486 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 1;Day -1,24 Hours Pre-dose | 0.470 10^9 cells per liter | Standard Deviation 0.127 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 1;Day 2,24 Hours Post-dose | 0.459 10^9 cells per liter | Standard Deviation 0.125 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 2;Day -1,24 Hours Pre-dose | 0.497 10^9 cells per liter | Standard Deviation 0.126 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Monocytes; Period 2;Day 2,24 Hours Post-dose | 0.457 10^9 cells per liter | Standard Deviation 0.122 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 1;Day -1,24 Hours Pre-dose | 2.924 10^9 cells per liter | Standard Deviation 0.706 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 1;Day 2,24 Hours Post-dose | 2.667 10^9 cells per liter | Standard Deviation 0.667 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 2;Day -1,24 Hours Pre-dose | 2.657 10^9 cells per liter | Standard Deviation 1.162 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Neutrophils;Period 2;Day 2,24 Hours Post-dose | 2.885 10^9 cells per liter | Standard Deviation 1.204 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 1;Day -1,24 Hours Pre-dose | 264.4 10^9 cells per liter | Standard Deviation 60.63 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 1;Day 2,24 Hours Post-dose | 244.5 10^9 cells per liter | Standard Deviation 64.6 |
| Cefixime Reference Formulation | Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points | Platelet; Period 2;Day -1,24 Hours Pre-dose | 289.6 10^9 cells per liter | Standard Deviation 72.29 |
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.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose | 67.0 Beats per minute | Standard Deviation 7.95 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 1; Day 1, 2 Hours Post-dose | 61.0 Beats per minute | Standard Deviation 8.17 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 1; Day 1, 4 Hours Post-dose | 61.9 Beats per minute | Standard Deviation 7.44 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 1; Day 1, 6 Hours Post-dose | 75.0 Beats per minute | Standard Deviation 8.74 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 66.5 Beats per minute | Standard Deviation 10.26 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose | 57.9 Beats per minute | Standard Deviation 9.08 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 2; Day 1, 2 Hours Post-dose | 54.1 Beats per minute | Standard Deviation 8.88 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 2; Day 1, 4 Hours Post-dose | 56.6 Beats per minute | Standard Deviation 8.67 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 2; Day 1, 6 Hours Post-dose | 68.5 Beats per minute | Standard Deviation 14.09 |
| SKF101804 Cefixime | Pulse Rate at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 59.2 Beats per minute | Standard Deviation 7.59 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 2; Day 1, 4 Hours Post-dose | 62.8 Beats per minute | Standard Deviation 7.92 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose | 58.1 Beats per minute | Standard Deviation 8.76 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose | 65.1 Beats per minute | Standard Deviation 6.85 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 1; Day 1, 2 Hours Post-dose | 55.1 Beats per minute | Standard Deviation 8.32 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 67.1 Beats per minute | Standard Deviation 8.62 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 1; Day 1, 4 Hours Post-dose | 55.6 Beats per minute | Standard Deviation 7.49 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 2; Day 1, 2 Hours Post-dose | 63.1 Beats per minute | Standard Deviation 8.87 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 1; Day 1, 6 Hours Post-dose | 67.2 Beats per minute | Standard Deviation 12.97 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 2; Day 1, 6 Hours Post-dose | 75.1 Beats per minute | Standard Deviation 8.82 |
| Cefixime Reference Formulation | Pulse Rate at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 54.3 Beats per minute | Standard Deviation 7.22 |
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.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose | 15.0 Breaths per minute | Standard Deviation 1.11 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 2 Hours Post-dose | 17.3 Breaths per minute | Standard Deviation 2.02 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 4 Hours Post-dose | 15.5 Breaths per minute | Standard Deviation 2.1 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 6 Hours Post-dose | 15.0 Breaths per minute | Standard Deviation 2 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 15.9 Breaths per minute | Standard Deviation 2.14 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose | 15.8 Breaths per minute | Standard Deviation 1.19 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 2 Hours Post-dose | 18.4 Breaths per minute | Standard Deviation 1.65 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 4 Hours Post-dose | 16.7 Breaths per minute | Standard Deviation 3.1 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 6 Hours Post-dose | 17.9 Breaths per minute | Standard Deviation 1.46 |
| SKF101804 Cefixime | Respiratory Rate at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 16.2 Breaths per minute | Standard Deviation 1.25 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 4 Hours Post-dose | 18.4 Breaths per minute | Standard Deviation 1.65 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 1.5 Hours Pre-dose | 15.7 Breaths per minute | Standard Deviation 0.73 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 1.5 Hours Pre-dose | 15.6 Breaths per minute | Standard Deviation 0.74 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 2 Hours Post-dose | 17.0 Breaths per minute | Standard Deviation 2.69 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 16.0 Breaths per minute | Standard Deviation 2.22 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 4 Hours Post-dose | 14.2 Breaths per minute | Standard Deviation 1.25 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 2 Hours Post-dose | 18.2 Breaths per minute | Standard Deviation 1.72 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 1; Day 1, 6 Hours Post-dose | 14.8 Breaths per minute | Standard Deviation 0.97 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 2; Day 1, 6 Hours Post-dose | 19.0 Breaths per minute | Standard Deviation 1.04 |
| Cefixime Reference Formulation | Respiratory Rate at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 16.1 Breaths per minute | Standard Deviation 2.95 |
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.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 1.5 Hours Pre-dose | 110.6 Millimeters of mercury | Standard Deviation 8.22 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 2 Hours Post-dose | 113.4 Millimeters of mercury | Standard Deviation 7.3 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 4 Hours Post-dose | 112.3 Millimeters of mercury | Standard Deviation 8.39 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 6 Hours Post-dose | 111.6 Millimeters of mercury | Standard Deviation 7.17 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 2, 24 Hours Post-dose | 110.9 Millimeters of mercury | Standard Deviation 6.86 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 1.5 Hours Pre-dose | 110.4 Millimeters of mercury | Standard Deviation 3.97 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 2 Hours Post-dose | 113.1 Millimeters of mercury | Standard Deviation 6.24 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 4 Hours Post-dose | 112.6 Millimeters of mercury | Standard Deviation 8.53 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 6 Hours Post-dose | 109.6 Millimeters of mercury | Standard Deviation 7.14 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 2, 24 Hours Post-dose | 113.1 Millimeters of mercury | Standard Deviation 6.24 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 1.5 Hours Pre-dose | 62.9 Millimeters of mercury | Standard Deviation 6.59 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 1.5 Hours Pre-dose | 111.2 Millimeters of mercury | Standard Deviation 10.09 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 2 Hours Post-dose | 66.2 Millimeters of mercury | Standard Deviation 7.65 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 4 Hours Post-dose | 63.5 Millimeters of mercury | Standard Deviation 8.55 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 2 Hours Post-dose | 62.9 Millimeters of mercury | Standard Deviation 7.69 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 4 Hours Post-dose | 62.5 Millimeters of mercury | Standard Deviation 5.43 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 6 Hours Post-dose | 59.3 Millimeters of mercury | Standard Deviation 3.89 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 2, 24 Hours Post-dose | 63.0 Millimeters of mercury | Standard Deviation 6.8 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 6 Hours Post-dose | 59.4 Millimeters of mercury | Standard Deviation 4.97 |
| SKF101804 Cefixime | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 2, 24 Hours Post-dose | 63.9 Millimeters of mercury | Standard Deviation 7.41 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 4 Hours Post-dose | 63.3 Millimeters of mercury | Standard Deviation 6.94 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 1.5 Hours Pre-dose | 110.9 Millimeters of mercury | Standard Deviation 6.39 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 1.5 Hours Pre-dose | 61.8 Millimeters of mercury | Standard Deviation 7.2 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 2 Hours Post-dose | 111.3 Millimeters of mercury | Standard Deviation 8.68 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 2, 24 Hours Post-dose | 67.7 Millimeters of mercury | Standard Deviation 7.9 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 4 Hours Post-dose | 112.1 Millimeters of mercury | Standard Deviation 4.25 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 2 Hours Post-dose | 63.1 Millimeters of mercury | Standard Deviation 9.12 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 1, 6 Hours Post-dose | 108.6 Millimeters of mercury | Standard Deviation 6.46 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 6 Hours Post-dose | 59.6 Millimeters of mercury | Standard Deviation 5.09 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 1; Day 2, 24 Hours Post-dose | 115.4 Millimeters of mercury | Standard Deviation 7 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 4 Hours Post-dose | 62.6 Millimeters of mercury | Standard Deviation 8.21 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 1.5 Hours Pre-dose | 111.2 Millimeters of mercury | Standard Deviation 10.09 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 2 Hours Post-dose | 112.7 Millimeters of mercury | Standard Deviation 10.94 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 1.5 Hours Pre-dose | 64.1 Millimeters of mercury | Standard Deviation 7.76 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 4 Hours Post-dose | 111.1 Millimeters of mercury | Standard Deviation 9.79 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 2; Day 1, 6 Hours Post-dose | 60.2 Millimeters of mercury | Standard Deviation 7.79 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 1, 6 Hours Post-dose | 109.5 Millimeters of mercury | Standard Deviation 8.98 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 1, 2 Hours Post-dose | 60.9 Millimeters of mercury | Standard Deviation 6.38 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | SBP, Period 2; Day 2, 24 Hours Post-dose | 113.6 Millimeters of mercury | Standard Deviation 9.05 |
| Cefixime Reference Formulation | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points | DBP, Period 1; Day 2, 24 Hours Post-dose | 66.2 Millimeters of mercury | Standard Deviation 7.65 |
Secondary
Terminal Phase Half-life (T1/2) for Cefixime
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 cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SKF101804 Cefixime | Terminal Phase Half-life (T1/2) for Cefixime | 3.18 Hours | Geometric Coefficient of Variation 15 |
| Cefixime Reference Formulation | Terminal Phase Half-life (T1/2) for Cefixime | 3.13 Hours | Geometric Coefficient of Variation 14.7 |
Secondary
Time of Occurrence of Cmax (Tmax) for Cefixime
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 cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SKF101804 Cefixime | Time of Occurrence of Cmax (Tmax) for Cefixime | 4.005 Hours |
| Cefixime Reference Formulation | Time of Occurrence of Cmax (Tmax) for Cefixime | 4.005 Hours |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day -1, 24 Hours Pre-dose | 82.4 Micromoles per liter | Standard Deviation 15.29 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day 2, 24 Hours Post-dose | 79.9 Micromoles per liter | Standard Deviation 12 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 2; Day -1, 24 Hours Pre-dose | 81.1 Micromoles per liter | Standard Deviation 14.31 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 2; Day 2, 24 Hours Post-dose | 83.9 Micromoles per liter | Standard Deviation 15.33 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period1;Day -1, 24 Hours Pre-dose | 10.14 Micromoles per liter | Standard Deviation 4.633 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period1;Day 2, 24 Hours Post-dose | 6.83 Micromoles per liter | Standard Deviation 3.004 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period2;Day -1, 24 Hours Pre-dose | 9.90 Micromoles per liter | Standard Deviation 7.205 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period2;Day 2, 24 Hours Post-dose | 6.47 Micromoles per liter | Standard Deviation 3.749 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period1;Day -1, 24 Hours Pre-dose | 3.68 Micromoles per liter | Standard Deviation 1.294 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period1;Day 2, 24 Hours Post-dose | 2.65 Micromoles per liter | Standard Deviation 0.959 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period2;Day -1, 24 Hours Pre-dose | 3.58 Micromoles per liter | Standard Deviation 1.945 |
| SKF101804 Cefixime | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period2;Day 2, 24 Hours Post-dose | 2.55 Micromoles per liter | Standard Deviation 1.149 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period2;Day -1, 24 Hours Pre-dose | 3.12 Micromoles per liter | Standard Deviation 1.057 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day -1, 24 Hours Pre-dose | 83.4 Micromoles per liter | Standard Deviation 15.45 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period2;Day -1, 24 Hours Pre-dose | 8.22 Micromoles per liter | Standard Deviation 3.516 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 1; Day 2, 24 Hours Post-dose | 85.9 Micromoles per liter | Standard Deviation 15.59 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period1;Day 2, 24 Hours Post-dose | 2.93 Micromoles per liter | Standard Deviation 1.63 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 2; Day -1, 24 Hours Pre-dose | 78.5 Micromoles per liter | Standard Deviation 14.21 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period2;Day 2, 24 Hours Post-dose | 6.16 Micromoles per liter | Standard Deviation 2.843 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Creat; Period 2; Day 2, 24 Hours Post-dose | 78.4 Micromoles per liter | Standard Deviation 12.71 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period2;Day 2, 24 Hours Post-dose | 2.49 Micromoles per liter | Standard Deviation 0.972 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period1;Day -1, 24 Hours Pre-dose | 10.99 Micromoles per liter | Standard Deviation 6.235 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Direct bil; Period1;Day -1, 24 Hours Pre-dose | 4.01 Micromoles per liter | Standard Deviation 1.794 |
| Cefixime Reference Formulation | Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points | Total bil; Period1;Day 2, 24 Hours Post-dose | 8.10 Micromoles per liter | Standard Deviation 6.191 |
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.
Time frame: Day -1 and Day 2 of each treatment period
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SKF101804 Cefixime | Total Protein at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 74.34 Grams per liter | Standard Deviation 3.354 |
| SKF101804 Cefixime | Total Protein at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 73.76 Grams per liter | Standard Deviation 3.995 |
| SKF101804 Cefixime | Total Protein at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 67.90 Grams per liter | Standard Deviation 3.295 |
| SKF101804 Cefixime | Total Protein at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 67.64 Grams per liter | Standard Deviation 3.181 |
| Cefixime Reference Formulation | Total Protein at Indicated Time-points | Period 1; Day 2, 24 Hours Post-dose | 67.97 Grams per liter | Standard Deviation 2.635 |
| Cefixime Reference Formulation | Total Protein at Indicated Time-points | Period 1; Day -1, 24 Hours Pre-dose | 74.77 Grams per liter | Standard Deviation 4.725 |
| Cefixime Reference Formulation | Total Protein at Indicated Time-points | Period 2; Day 2, 24 Hours Post-dose | 67.89 Grams per liter | Standard Deviation 4.211 |
| Cefixime Reference Formulation | Total Protein at Indicated Time-points | Period 2; Day -1, 24 Hours Pre-dose | 72.57 Grams per liter | Standard Deviation 3.886 |