Trial Outcomes & Findings for Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions (NCT NCT03408392)
NCT ID: NCT03408392
Last Updated: 2020-02-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
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
Results posted on
2020-02-25
Participant Flow
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.
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.
Participant milestones
| Measure |
SKF101804 Cefixime Followed by Cefixime Reference Formulation
Eligible participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 2.
|
Cefixime Reference Formulation Followed by SKF101804 Cefixime
Eligible participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 2.
|
|---|---|---|
|
Treatment Period 1 (16 Days)
STARTED
|
14
|
14
|
|
Treatment Period 1 (16 Days)
COMPLETED
|
14
|
14
|
|
Treatment Period 1 (16 Days)
NOT COMPLETED
|
0
|
0
|
|
Wash-out Period (14 Days)
STARTED
|
14
|
14
|
|
Wash-out Period (14 Days)
COMPLETED
|
14
|
14
|
|
Wash-out Period (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (16 Days)
STARTED
|
14
|
14
|
|
Treatment Period 2 (16 Days)
COMPLETED
|
14
|
14
|
|
Treatment Period 2 (16 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
All Participants
n=28 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.
|
|---|---|
|
Age, Continuous
|
28.9 Years
STANDARD_DEVIATION 7.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
19000 Hour*nanogram per milliliter
Geometric Coefficient of Variation 34.3
|
PRIMARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime
|
2670 Nanogram per milliliter
Geometric Coefficient of Variation 29.4
|
2640 Nanogram per milliliter
Geometric Coefficient of Variation 30.5
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
19700 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33.3
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Time of Occurrence of Cmax (Tmax) for Cefixime
|
4.005 Hours
Interval 2.5 to 6.02
|
4.005 Hours
Interval 2.02 to 4.51
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime
|
3.24 Percentage of AUCex
Geometric Coefficient of Variation 51.4
|
3.32 Percentage of AUCex
Geometric Coefficient of Variation 67.8
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Terminal Phase Half-life (T1/2) for Cefixime
|
3.18 Hours
Geometric Coefficient of Variation 15.0
|
3.13 Hours
Geometric Coefficient of Variation 14.7
|
SECONDARY outcome
Timeframe: Up to Day 16 in each treatment periodPopulation: Safety Population
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=28 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=28 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
Non-serious AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
14.0 Units per liter
Standard Deviation 5.76
|
|
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 6.00
|
19.9 Units per liter
Standard Deviation 4.57
|
|
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
|
15.6 Units per liter
Standard Deviation 5.67
|
|
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
|
16.7 Units per liter
Standard Deviation 9.15
|
|
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
|
14.9 Units per liter
Standard Deviation 7.68
|
|
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
|
74.8 Units per liter
Standard Deviation 18.25
|
|
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
|
67.1 Units per liter
Standard Deviation 15.23
|
|
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
|
80.9 Units per liter
Standard Deviation 15.81
|
|
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
|
76.9 Units per liter
Standard Deviation 15.13
|
|
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 4.40
|
20.6 Units per liter
Standard Deviation 4.22
|
|
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
|
17.1 Units per liter
Standard Deviation 3.45
|
|
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
|
17.8 Units per liter
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
12.258 Milligrams per deciliter
Standard Deviation 2.664
|
|
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
|
11.844 Milligrams per deciliter
Standard Deviation 2.017
|
|
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
|
10.300 Milligrams per deciliter
Standard Deviation 4.120
|
|
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
|
12.796 Milligrams per deciliter
Standard Deviation 1.599
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
2.399 Millimoles per liter
Standard Deviation 0.134
|
|
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
|
2.304 Millimoles per liter
Standard Deviation 0.076
|
|
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
|
2.376 Millimoles per liter
Standard Deviation 0.060
|
|
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
|
2.378 Millimoles per liter
Standard Deviation 0.081
|
|
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
|
4.616 Millimoles per liter
Standard Deviation 0.267
|
|
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
|
4.676 Millimoles per liter
Standard Deviation 0.295
|
|
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
|
4.571 Millimoles per liter
Standard Deviation 0.404
|
|
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
|
4.812 Millimoles per liter
Standard Deviation 0.278
|
|
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 1.460
|
145.00 Millimoles per liter
Standard Deviation 1.414
|
|
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
|
141.43 Millimoles per liter
Standard Deviation 1.604
|
|
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
|
141.50 Millimoles per liter
Standard Deviation 1.912
|
|
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
|
139.64 Millimoles per liter
Standard Deviation 1.550
|
|
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
|
4.404 Millimoles per liter
Standard Deviation 0.316
|
|
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
|
4.286 Millimoles per liter
Standard Deviation 0.206
|
|
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 0.220
|
4.521 Millimoles per liter
Standard Deviation 0.346
|
|
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
|
4.555 Millimoles per liter
Standard Deviation 0.402
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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 12.00
|
85.9 Micromoles per liter
Standard Deviation 15.59
|
|
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
|
83.4 Micromoles per liter
Standard Deviation 15.45
|
|
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
|
78.5 Micromoles per liter
Standard Deviation 14.21
|
|
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
|
78.4 Micromoles per liter
Standard Deviation 12.71
|
|
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
|
10.99 Micromoles per liter
Standard Deviation 6.235
|
|
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
|
8.10 Micromoles per liter
Standard Deviation 6.191
|
|
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
|
8.22 Micromoles per liter
Standard Deviation 3.516
|
|
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
|
6.16 Micromoles per liter
Standard Deviation 2.843
|
|
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
|
4.01 Micromoles per liter
Standard Deviation 1.794
|
|
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
|
2.93 Micromoles per liter
Standard Deviation 1.630
|
|
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
|
3.12 Micromoles per liter
Standard Deviation 1.057
|
|
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
|
2.49 Micromoles per liter
Standard Deviation 0.972
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Total Protein at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose
|
74.34 Grams per liter
Standard Deviation 3.354
|
74.77 Grams per liter
Standard Deviation 4.725
|
|
Total Protein at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
67.90 Grams per liter
Standard Deviation 3.295
|
67.97 Grams per liter
Standard Deviation 2.635
|
|
Total Protein at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose
|
73.76 Grams per liter
Standard Deviation 3.995
|
72.57 Grams per liter
Standard Deviation 3.886
|
|
Total Protein at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
67.64 Grams per liter
Standard Deviation 3.181
|
67.89 Grams per liter
Standard Deviation 4.211
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
5.463 10^9 cells per liter
Standard Deviation 1.388
|
|
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
|
5.477 10^9 cells per liter
Standard Deviation 1.571
|
|
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
|
2.667 10^9 cells per liter
Standard Deviation 0.667
|
|
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
|
2.657 10^9 cells per liter
Standard Deviation 1.162
|
|
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
|
2.885 10^9 cells per liter
Standard Deviation 1.204
|
|
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
|
264.4 10^9 cells per liter
Standard Deviation 60.63
|
|
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
|
244.5 10^9 cells per liter
Standard Deviation 64.60
|
|
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
|
289.6 10^9 cells per liter
Standard Deviation 72.29
|
|
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
|
274.2 10^9 cells per liter
Standard Deviation 68.61
|
|
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
|
0.022 10^9 cells per liter
Standard Deviation 0.013
|
|
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
|
0.025 10^9 cells per liter
Standard Deviation 0.011
|
|
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
|
0.029 10^9 cells per liter
Standard Deviation 0.025
|
|
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
|
0.022 10^9 cells per liter
Standard Deviation 0.026
|
|
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 0.130
|
0.182 10^9 cells per liter
Standard Deviation 0.157
|
|
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 0.130
|
0.204 10^9 cells per liter
Standard Deviation 0.199
|
|
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 0.230
|
0.139 10^9 cells per liter
Standard Deviation 0.144
|
|
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
|
0.156 10^9 cells per liter
Standard Deviation 0.182
|
|
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
|
5.752 10^9 cells per liter
Standard Deviation 0.907
|
|
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
|
5.394 10^9 cells per liter
Standard Deviation 1.019
|
|
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
|
2.154 10^9 cells per liter
Standard Deviation 0.493
|
|
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
|
2.039 10^9 cells per liter
Standard Deviation 0.459
|
|
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
|
2.141 10^9 cells per liter
Standard Deviation 0.409
|
|
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
|
1.956 10^9 cells per liter
Standard Deviation 0.486
|
|
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
|
0.470 10^9 cells per liter
Standard Deviation 0.127
|
|
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
|
0.459 10^9 cells per liter
Standard Deviation 0.125
|
|
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
|
0.497 10^9 cells per liter
Standard Deviation 0.126
|
|
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 0.160
|
0.457 10^9 cells per liter
Standard Deviation 0.122
|
|
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
|
2.924 10^9 cells per liter
Standard Deviation 0.706
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose
|
85.73 Femtoliter
Standard Deviation 2.834
|
84.86 Femtoliter
Standard Deviation 4.946
|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
85.30 Femtoliter
Standard Deviation 2.796
|
84.50 Femtoliter
Standard Deviation 4.895
|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose
|
84.83 Femtoliter
Standard Deviation 4.975
|
85.97 Femtoliter
Standard Deviation 2.903
|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
84.46 Femtoliter
Standard Deviation 4.878
|
85.41 Femtoliter
Standard Deviation 2.847
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose
|
29.58 Picogram
Standard Deviation 1.212
|
29.44 Picogram
Standard Deviation 2.140
|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
29.75 Picogram
Standard Deviation 1.295
|
29.51 Picogram
Standard Deviation 2.190
|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose
|
29.40 Picogram
Standard Deviation 2.242
|
29.68 Picogram
Standard Deviation 1.207
|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
29.54 Picogram
Standard Deviation 2.112
|
29.75 Picogram
Standard Deviation 1.320
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
5.020 10^12 cells per liter
Standard Deviation 0.480
|
|
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
|
4.871 10^12 cells per liter
Standard Deviation 0.424
|
|
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
|
4.971 10^12 cells per liter
Standard Deviation 0.473
|
|
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
|
4.906 10^12 cells per liter
Standard Deviation 0.494
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
0.411 Proportion of red blood cells in blood
Standard Deviation 0.038
|
|
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
|
0.426 Proportion of red blood cells in blood
Standard Deviation 0.043
|
|
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
|
0.427 Proportion of red blood cells in blood
Standard Deviation 0.040
|
|
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
|
0.419 Proportion of red blood cells in blood
Standard Deviation 0.041
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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 1.030
|
34.68 Grams per deciliter
Standard Deviation 0.957
|
|
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
|
34.89 Grams per deciliter
Standard Deviation 1.100
|
|
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 1.100
|
34.54 Grams per deciliter
Standard Deviation 0.880
|
|
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
|
34.82 Grams per deciliter
Standard Deviation 1.062
|
|
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
|
14.79 Grams per deciliter
Standard Deviation 1.833
|
|
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
|
14.38 Grams per deciliter
Standard Deviation 1.623
|
|
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
|
14.76 Grams per deciliter
Standard Deviation 1.591
|
|
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
|
14.60 Grams per deciliter
Standard Deviation 1.708
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Percent Reticulocytes at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose
|
1.786 Percentage of reticulocytes
Standard Deviation 0.361
|
1.700 Percentage of reticulocytes
Standard Deviation 0.346
|
|
Percent Reticulocytes at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
1.757 Percentage of reticulocytes
Standard Deviation 0.384
|
1.571 Percentage of reticulocytes
Standard Deviation 0.297
|
|
Percent Reticulocytes at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose
|
1.729 Percentage of reticulocytes
Standard Deviation 0.397
|
1.886 Percentage of reticulocytes
Standard Deviation 0.335
|
|
Percent Reticulocytes at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
2.350 Percentage of reticulocytes
Standard Deviation 2.176
|
1.743 Percentage of reticulocytes
Standard Deviation 0.361
|
SECONDARY outcome
Timeframe: Day -1 and Day 2 of each treatment periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Respiratory Rate at Indicated Time-points
Period 1; Day 1, 1.5 Hours Pre-dose
|
15.0 Breaths per minute
Standard Deviation 1.11
|
15.7 Breaths per minute
Standard Deviation 0.73
|
|
Respiratory Rate at Indicated Time-points
Period 1; Day 1, 2 Hours Post-dose
|
17.3 Breaths per minute
Standard Deviation 2.02
|
17.0 Breaths per minute
Standard Deviation 2.69
|
|
Respiratory Rate at Indicated Time-points
Period 1; Day 1, 4 Hours Post-dose
|
15.5 Breaths per minute
Standard Deviation 2.10
|
14.2 Breaths per minute
Standard Deviation 1.25
|
|
Respiratory Rate at Indicated Time-points
Period 1; Day 1, 6 Hours Post-dose
|
15.0 Breaths per minute
Standard Deviation 2.00
|
14.8 Breaths per minute
Standard Deviation 0.97
|
|
Respiratory Rate at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
15.9 Breaths per minute
Standard Deviation 2.14
|
16.1 Breaths per minute
Standard Deviation 2.95
|
|
Respiratory Rate at Indicated Time-points
Period 2; Day 1, 1.5 Hours Pre-dose
|
15.8 Breaths per minute
Standard Deviation 1.19
|
15.6 Breaths per minute
Standard Deviation 0.74
|
|
Respiratory Rate at Indicated Time-points
Period 2; Day 1, 2 Hours Post-dose
|
18.4 Breaths per minute
Standard Deviation 1.65
|
18.2 Breaths per minute
Standard Deviation 1.72
|
|
Respiratory Rate at Indicated Time-points
Period 2; Day 1, 4 Hours Post-dose
|
16.7 Breaths per minute
Standard Deviation 3.10
|
18.4 Breaths per minute
Standard Deviation 1.65
|
|
Respiratory Rate at Indicated Time-points
Period 2; Day 1, 6 Hours Post-dose
|
17.9 Breaths per minute
Standard Deviation 1.46
|
19.0 Breaths per minute
Standard Deviation 1.04
|
|
Respiratory Rate at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
16.2 Breaths per minute
Standard Deviation 1.25
|
16.0 Breaths per minute
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Pulse Rate at Indicated Time-points
Period 1; Day 1, 1.5 Hours Pre-dose
|
67.0 Beats per minute
Standard Deviation 7.95
|
58.1 Beats per minute
Standard Deviation 8.76
|
|
Pulse Rate at Indicated Time-points
Period 1; Day 1, 2 Hours Post-dose
|
61.0 Beats per minute
Standard Deviation 8.17
|
55.1 Beats per minute
Standard Deviation 8.32
|
|
Pulse Rate at Indicated Time-points
Period 1; Day 1, 4 Hours Post-dose
|
61.9 Beats per minute
Standard Deviation 7.44
|
55.6 Beats per minute
Standard Deviation 7.49
|
|
Pulse Rate at Indicated Time-points
Period 1; Day 1, 6 Hours Post-dose
|
75.0 Beats per minute
Standard Deviation 8.74
|
67.2 Beats per minute
Standard Deviation 12.97
|
|
Pulse Rate at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
66.5 Beats per minute
Standard Deviation 10.26
|
54.3 Beats per minute
Standard Deviation 7.22
|
|
Pulse Rate at Indicated Time-points
Period 2; Day 1, 1.5 Hours Pre-dose
|
57.9 Beats per minute
Standard Deviation 9.08
|
65.1 Beats per minute
Standard Deviation 6.85
|
|
Pulse Rate at Indicated Time-points
Period 2; Day 1, 2 Hours Post-dose
|
54.1 Beats per minute
Standard Deviation 8.88
|
63.1 Beats per minute
Standard Deviation 8.87
|
|
Pulse Rate at Indicated Time-points
Period 2; Day 1, 4 Hours Post-dose
|
56.6 Beats per minute
Standard Deviation 8.67
|
62.8 Beats per minute
Standard Deviation 7.92
|
|
Pulse Rate at Indicated Time-points
Period 2; Day 1, 6 Hours Post-dose
|
68.5 Beats per minute
Standard Deviation 14.09
|
75.1 Beats per minute
Standard Deviation 8.82
|
|
Pulse Rate at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
59.2 Beats per minute
Standard Deviation 7.59
|
67.1 Beats per minute
Standard Deviation 8.62
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
Body Temperature at Indicated Time-points
Period 1; Day 1, 1.5 Hours Pre-dose
|
36.19 Degree Celsius
Standard Deviation 0.305
|
36.27 Degree Celsius
Standard Deviation 0.336
|
|
Body Temperature at Indicated Time-points
Period 1; Day 1, 2 Hours Post-dose
|
36.38 Degree Celsius
Standard Deviation 0.333
|
36.23 Degree Celsius
Standard Deviation 0.261
|
|
Body Temperature at Indicated Time-points
Period 1; Day 1, 4 Hours Post-dose
|
36.48 Degree Celsius
Standard Deviation 0.336
|
36.59 Degree Celsius
Standard Deviation 0.352
|
|
Body Temperature at Indicated Time-points
Period 1; Day 1, 6 Hours Post-dose
|
36.64 Degree Celsius
Standard Deviation 0.303
|
36.79 Degree Celsius
Standard Deviation 0.202
|
|
Body Temperature at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose
|
36.29 Degree Celsius
Standard Deviation 0.317
|
36.24 Degree Celsius
Standard Deviation 0.365
|
|
Body Temperature at Indicated Time-points
Period 2; Day 1, 1.5 Hours Pre-dose
|
36.28 Degree Celsius
Standard Deviation 0.372
|
36.29 Degree Celsius
Standard Deviation 0.317
|
|
Body Temperature at Indicated Time-points
Period 2; Day 1, 2 Hours Post-dose
|
36.51 Degree Celsius
Standard Deviation 0.400
|
36.42 Degree Celsius
Standard Deviation 0.404
|
|
Body Temperature at Indicated Time-points
Period 2; Day 1, 4 Hours Post-dose
|
36.58 Degree Celsius
Standard Deviation 0.347
|
36.51 Degree Celsius
Standard Deviation 0.243
|
|
Body Temperature at Indicated Time-points
Period 2; Day 1, 6 Hours Post-dose
|
36.10 Degree Celsius
Standard Deviation 0.421
|
36.63 Degree Celsius
Standard Deviation 0.300
|
|
Body Temperature at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose
|
36.30 Degree Celsius
Standard Deviation 0.321
|
36.11 Degree Celsius
Standard Deviation 0.434
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
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.
Outcome measures
| Measure |
SKF101804 Cefixime
n=14 Participants
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
Cefixime Reference Formulation
n=14 Participants
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
|
|---|---|---|
|
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
|
110.9 Millimeters of mercury
Standard Deviation 6.39
|
|
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 7.30
|
111.3 Millimeters of mercury
Standard Deviation 8.68
|
|
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
|
112.1 Millimeters of mercury
Standard Deviation 4.25
|
|
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
|
108.6 Millimeters of mercury
Standard Deviation 6.46
|
|
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
|
115.4 Millimeters of mercury
Standard Deviation 7.00
|
|
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
|
111.2 Millimeters of mercury
Standard Deviation 10.09
|
|
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
|
112.7 Millimeters of mercury
Standard Deviation 10.94
|
|
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
|
111.1 Millimeters of mercury
Standard Deviation 9.79
|
|
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
|
109.5 Millimeters of mercury
Standard Deviation 8.98
|
|
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
|
113.6 Millimeters of mercury
Standard Deviation 9.05
|
|
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
|
64.1 Millimeters of mercury
Standard Deviation 7.76
|
|
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
|
60.9 Millimeters of mercury
Standard Deviation 6.38
|
|
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
|
63.3 Millimeters of mercury
Standard Deviation 6.94
|
|
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
|
59.6 Millimeters of mercury
Standard Deviation 5.09
|
|
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 6.80
|
66.2 Millimeters of mercury
Standard Deviation 7.65
|
|
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
|
61.8 Millimeters of mercury
Standard Deviation 7.20
|
|
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
|
63.1 Millimeters of mercury
Standard Deviation 9.12
|
|
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
|
62.6 Millimeters of mercury
Standard Deviation 8.21
|
|
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
|
60.2 Millimeters of mercury
Standard Deviation 7.79
|
|
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
|
67.7 Millimeters of mercury
Standard Deviation 7.90
|
Adverse Events
SKF101804 Cefixime
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cefixime Reference Formulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER