Trial Outcomes & Findings for Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions (NCT NCT00836901)
NCT ID: NCT00836901
Last Updated: 2024-08-21
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Blood samples collected over 10 hour period
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
Amoxicillin Clavulanic Acid (Test) First
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
|
Augmentin® (Reference) First
Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
24
|
28
|
|
First Intervention
COMPLETED
|
23
|
28
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
23
|
28
|
|
Second Intervention
COMPLETED
|
23
|
28
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Amoxicillin Clavulanic Acid (Test) First
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
|
Augmentin® (Reference) First
Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Amoxicillin Clavulanic Acid (Test) First
n=24 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
|
Augmentin® (Reference) First
n=28 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 10 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=51 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=51 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Amoxicillin
|
4482.26 ng/mL
Standard Deviation 1157.70
|
4549.67 ng/mL
Standard Deviation 1116.01
|
PRIMARY outcome
Timeframe: Blood samples collected over 10 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=51 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=51 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
|
19403.12 ng*h/mL
Standard Deviation 4003.43
|
19518.22 ng*h/mL
Standard Deviation 3573.61
|
PRIMARY outcome
Timeframe: Blood samples collected over 10 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=51 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=51 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
|
18299.44 ng*h/mL
Standard Deviation 3147.95
|
18746.55 ng*h/mL
Standard Deviation 3331.60
|
PRIMARY outcome
Timeframe: Blood samples were collected over 10 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis
Bioequivalence based on Cmax
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=51 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=51 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Clavulanic Acid
|
734.20 ng/mL
Standard Deviation 300.57
|
766.38 ng/mL
Standard Deviation 299.31
|
PRIMARY outcome
Timeframe: Blood samples collected over 10 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=51 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=51 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid
|
1772.85 ng*h/mL
Standard Deviation 664.55
|
1864.33 ng*h/mL
Standard Deviation 676.11
|
PRIMARY outcome
Timeframe: Blood samples collected over 10 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=51 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=51 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid
|
1693.67 ng*h/mL
Standard Deviation 654.95
|
1785.27 ng*h/mL
Standard Deviation 661.42
|
Adverse Events
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 Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER