Trial Outcomes & Findings for Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions (NCT NCT00835705)
NCT ID: NCT00835705
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Blood samples were collected over 10 hour period
Results posted on
2024-08-20
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
|
22
|
28
|
|
Second Intervention
NOT COMPLETED
|
1
|
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
Difficulty with vein
|
1
|
0
|
|
Second Intervention
Difficulty with vein
|
1
|
0
|
Baseline Characteristics
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under 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
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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 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=50 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=50 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Amoxicillin
|
7800.48 ng/mL
Standard Deviation 2113.68
|
7599.29 ng/mL
Standard Deviation 2222.97
|
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 AUC0-inf
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=50 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=50 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
|
19089.36 ng*h/mL
Standard Deviation 3440.49
|
19395.97 ng*h/mL
Standard Deviation 3670.87
|
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 AUC0-t
Outcome measures
| Measure |
Amoxicillin Clavulanic Acid
n=50 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=50 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
|
18939.13 ng*h/mL
Standard Deviation 3441.02
|
19263.26 ng*h/mL
Standard Deviation 3640.51
|
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=50 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=50 Participants
Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Clavulanic Acid
|
1483.32 ng/mL
Standard Deviation 508.73
|
1449.68 ng/mL
Standard Deviation 497.08
|
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=50 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=50 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)] - Clavulanic Acid
|
2876.99 ng*h/mL
Standard Deviation 1022.59
|
2833.74 ng*h/mL
Standard Deviation 1031.56
|
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=50 Participants
Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
|
Augmentin®
n=50 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
|
2798.69 ng*h/mL
Standard Deviation 1011.64
|
2749.12 ng*h/mL
Standard Deviation 1018.15
|
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