NCT00840099

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting 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 Fasting 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 objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting 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 fed
DRUG	Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension	1 x 600 mg/42.9 mg/5 mL, single-dose fed

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