Trial Outcomes & Findings for 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions (NCT NCT00840099)
NCT ID: NCT00840099
Last Updated: 2024-08-20
Results Overview
Cmax - Maximum Observed Concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Blood samples collected over 14 hour period
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Test First
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
|
Reference First
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
|
|---|---|---|
|
Period 1
STARTED
|
24
|
24
|
|
Period 1
COMPLETED
|
24
|
24
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
21
|
24
|
|
Period 2
COMPLETED
|
21
|
24
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Test First
n=24 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
|
Reference First
n=24 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
|
Total
n=48 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
|
24 Participants
n=7 Participants
|
48 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 14 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Cmax - Maximum Observed Concentration
Outcome measures
| Measure |
Amoxicillin Clavulanate
n=45 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
|
AugmentinES-600™
n=45 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
|
|---|---|---|
|
Bioequivalence Based on Cmax for Amoxicillin
|
10970.75 ng/mL
Standard Deviation 3084.93
|
10867.32 ng/mL
Standard Deviation 3136.62
|
PRIMARY outcome
Timeframe: Blood samples collected over 14 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Outcome measures
| Measure |
Amoxicillin Clavulanate
n=45 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
|
AugmentinES-600™
n=45 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
|
|---|---|---|
|
Bioequivalence Based on AUC0-inf for Amoxicillin
|
27965.57 ng*h/mL
Standard Deviation 5011.89
|
27147.08 ng*h/mL
Standard Deviation 4862.26
|
PRIMARY outcome
Timeframe: Blood samples collected over 14 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration
Outcome measures
| Measure |
Amoxicillin Clavulanate
n=45 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
|
AugmentinES-600™
n=45 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
|
|---|---|---|
|
Bioequivalence Based on AUC0-t for Amoxicillin
|
27464.27 ng*h/mL
Standard Deviation 4977.06
|
26666.90 ng*h/mL
Standard Deviation 4809.89
|
PRIMARY outcome
Timeframe: Blood samples collected over 14 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Cmax - Maximum Observed Concentration
Outcome measures
| Measure |
Amoxicillin Clavulanate
n=45 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
|
AugmentinES-600™
n=45 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
|
|---|---|---|
|
Bioequivalence Based on Cmax for Clavulanic Acid
|
1127.59 ng/mL
Standard Deviation 338.93
|
1106.84 ng/mL
Standard Deviation 353.38
|
PRIMARY outcome
Timeframe: Blood samples collected over 14 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Outcome measures
| Measure |
Amoxicillin Clavulanate
n=45 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
|
AugmentinES-600™
n=45 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
|
|---|---|---|
|
Bioequivalence Based on AUC0-inf for Clavulanic Acid
|
2396.58 ng*h/mL
Standard Deviation 753.32
|
2260.40 ng*h/mL
Standard Deviation 731.24
|
PRIMARY outcome
Timeframe: Blood samples collected over 14 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Outcome measures
| Measure |
Amoxicillin Clavulanate
n=45 Participants
Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
|
AugmentinES-600™
n=45 Participants
AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
|
|---|---|---|
|
Bioequivalence Based on AUC0-t for Clavulanic Acid
|
2293.69 ng*h/mL
Standard Deviation 747.25
|
2157.07 ng*h/mL
Standard Deviation 719.08
|
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 PI is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER