Trial Outcomes & Findings for A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects (NCT NCT02446496)
NCT ID: NCT02446496
Last Updated: 2017-09-21
Results Overview
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.
COMPLETED
PHASE4
24 participants
Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.
2017-09-21
Participant Flow
Total of 24 participants were enrolled in from March-2014 to April-2014. During each study period participants received test (treatment A-cefadroxil tablet) and reference (treatment B-cefadroxil tablet) products.
Total of 28 participants were screened, out of which 4 were screen failure. Of 4 participants, 1 withdrawn due to significant variation in laboratory results and 3 withdrawn upon their will.
Participant milestones
| Measure |
Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm
In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram \[gm\] film coated \[F.C.\] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
Baseline characteristics by cohort
| Measure |
Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram \[gm\] film coated \[F.C.\] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
|---|---|
|
Age, Continuous
|
26.46 Years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.Population: All subject population: who were crossed over and completed the balance design, were included in the calculation. All participants were present at the time of measurement.
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.
Outcome measures
| Measure |
Treatment A-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
Treatment B-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
|---|---|---|
|
Maximal Measured Plasma Concentration (Cmax) After a Single Dose
|
28.18 Microgram per milliliter
Geometric Coefficient of Variation 8.12
|
29.20 Microgram per milliliter
Geometric Coefficient of Variation 8.80
|
PRIMARY outcome
Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.Population: All subject population. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Area under the plasma concentration-time curve from time zero (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. Area under the plasma concentration-time curve from time zero (0) to infinity (AUC0-infinity) was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant (Ke), where first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.
Outcome measures
| Measure |
Treatment A-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
Treatment B-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)
AUC(0-t)
|
106.55 Microgram.hour per milliliter
Geometric Coefficient of Variation 28.64
|
102.21 Microgram.hour per milliliter
Geometric Coefficient of Variation 26.06
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)
AUC(0-infinity)
|
111.71 Microgram.hour per milliliter
Geometric Coefficient of Variation 30.15
|
106.08 Microgram.hour per milliliter
Geometric Coefficient of Variation 26.40
|
SECONDARY outcome
Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.Population: All subject population. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.
Outcome measures
| Measure |
Treatment A-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
Treatment B-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
|---|---|---|
|
Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)
T-max
|
1.50 Hour
Interval 0.75 to 4.0
|
1.50 Hour
Interval 0.75 to 3.0
|
|
Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)
T-half
|
2.28 Hour
Interval 1.89 to 3.13
|
2.10 Hour
Interval 1.72 to 3.85
|
SECONDARY outcome
Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.Population: All subject population. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.
Outcome measures
| Measure |
Treatment A-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
Treatment B-cefadroxil 1 gm
n=24 Participants
In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
|
|---|---|---|
|
Apparent First-order Elimination or Terminal Rate Constant (Ke)
|
0.30 Per hour
Standard Deviation 0.03
|
0.33 Per hour
Standard Deviation 0.05
|
Adverse Events
Treatment A-cefadroxil 1 gm
Treatment B-cefadroxil 1 gm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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