NCT00840840

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions

An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects, Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL	1 x 600 mg/42.9 mg/5 mL, single-dose fasting
DRUG	Augmentin ES-600™	1 x 600 mg/42.9 mg/5 mL, single-dose fasting

Timeline

• Start date: 2002-08-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2009-02-10
• Last updated: 2024-08-20
• Results posted: 2009-08-25

Locations

1 site across 1 country: Canada