clinical trial · NCT00840840
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 48
Healthy600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mLAugmentin ES-600™
brief 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.
started
Aug 1, 2002
primary completion
Aug 1, 2002
completion
Aug 1, 2002
last updated
Aug 20, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol