Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: amoxicillin-clavulanic acid; Drug: Augmentin®

• Registration Number: NCT00836901
• Lead Sponsor: Teva Pharmaceuticals USA

Brief Summary

The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Results First Submitted: 2009-05-07
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amoxicillin Calvulanic Acid	amoxicillin-clavulanic acid	Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 40-57 mg Chewable Tablet (reference) dosed in second period
Augmentin®	Augmentin®	Augmentin® 400-57 mg Chewable Tablet (test) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (reference) dosed in second period

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Observed Concentration) - Amoxicillin	Blood samples collected over 10 hour period	Bioequivalence based on Cmax
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin	Blood samples collected over 10 hour period	Bioequivalence based on AUC0-inf
AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin	Blood samples collected over 10 hour period	Bioequivalence based on AUC0-t
Cmax (Maximum Observed Concentration) - Clavulanic Acid	Blood samples were collected over 10 hour period	Bioequivalence based on Cmax
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid	Blood samples collected over 10 hour period	Bioequivalence based on AUC0-inf
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid	Blood samples collected over 10 hour period	Bioequivalence based on AUC0-t

Trial Locations

Locations (1)

Anapharm Inc.; 🇨🇦 Montreal, Quebec, Canada