Trial Outcomes & Findings for 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions (NCT NCT00840840)

NCT ID: NCT00840840

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	23	24
Period 2 COMPLETED	23	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 Fed 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	4 Participants n=7 Participants	7 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 period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Cmax - Maximum Observed Concentration

Outcome measures

Measure	Amoxicillin Clavulanate n=47 Participants Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period	AugmentinES-600™ n=47 Participants AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
Bioequivalence Based on Cmax for Amoxicillin	7331.46 ng/mL Standard Deviation 1414.94	7235.76 ng/mL Standard Deviation 1434.42

PRIMARY outcome

Timeframe: Blood samples collected over 14 hour period

Population: 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=47 Participants Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period	AugmentinES-600™ n=47 Participants AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
Bioequivalence Based on AUC0-inf for Amoxicillin	27318.54 ng*h/mL Standard Deviation 4774.49	26515.59 ng*h/mL Standard Deviation 4691.18

PRIMARY outcome

Timeframe: Blood samples collected over 14 hour period

Population: 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=47 Participants Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period	AugmentinES-600™ n=47 Participants AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
Bioequivalence Based on AUC0-t for Amoxicillin	26662.17 ng*h/mL Standard Deviation 4754.01	25906.24 ng*h/mL Standard Deviation 4662.03

PRIMARY outcome

Timeframe: Blood samples collected over 14 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Cmax - Maximum Observed Concentration

Outcome measures

Measure	Amoxicillin Clavulanate n=47 Participants Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period	AugmentinES-600™ n=47 Participants AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
Bioequivalence Based on Cmax for Clavulanic Acid	516.42 ng/mL Standard Deviation 197.44	507.38 ng/mL Standard Deviation 162.09

PRIMARY outcome

Timeframe: Blood samples collected over 14 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

AUC0-inf - Area under the concentration-time curve from zero to infinity (extrapolated)

Outcome measures

Measure	Amoxicillin Clavulanate n=47 Participants Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period	AugmentinES-600™ n=47 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	1335.73 ng*h/mL Standard Deviation 628.13	1283.73 ng*h/mL Standard Deviation 508.17

PRIMARY outcome

Timeframe: Blood samples collected over 14 hour period

Population: 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=47 Participants Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period	AugmentinES-600™ n=47 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	1241.09 ng/h/mL Standard Deviation 627.50	1195.82 ng/h/mL Standard Deviation 503.91

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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