NCT00840281

Cefprozil 500 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of Cefprozil 500 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (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 cefprozil 500 mg tablets (Teva Pharmaceuticals USA) with that of Cefzil® 500 mg tablets (Bristol-Myers Squibb) in healthy, non-smoking adults under fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cefzil® 500 mg tablets	1 x 500 mg, single-dose fasting
DRUG	Cefprozil 500 mg Tablets	1 x 500 mg, single-dose fasting

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2009-02-10
• Last updated: 2024-08-20
• Results posted: 2009-07-21

Locations

1 site across 1 country: United States