clinical trial · NCT00835081
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
Teva Pharmaceuticals USA·phase1·completed·n = 26
HealthyCefadroxil 500 mg CapsulesDURICEF® capsules 500 mg
brief summary
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
started
Sep 1, 2004
primary completion
Oct 1, 2004
completion
Oct 1, 2004
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Two-Way , Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefadroxil 500 mg Capsules Versus DURICEF® 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol