clinical trial · NCT00836901
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 52
Healthyamoxicillin-clavulanic acidAugmentin®
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.
started
Sep 1, 2003
primary completion
Sep 1, 2003
completion
Sep 1, 2003
last updated
Aug 21, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol