NCT00835081

Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cefadroxil 500 mg Capsules	1 x 500 mg
DRUG	DURICEF® capsules 500 mg	1 x 500 mg

Timeline

• Start date: 2004-09-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-07-21

Locations

2 sites across 2 countries: United States, Canada