NCT00835614

Cefprozil for Oral Suspension 250 mg/5 mL, Fasting

A Relative Bioavailability Study of Cefprozil for Oral Suspension 250 mg/5 mL Under Fasting Conditions

• 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 cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (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	Cefprozil for oral suspension 250 mg/5 mL	1 x 250 mg/5 mL, single-dose fasting
DRUG	CEFZIL® for Oral Suspension 250 mg/5mL	1 x 250 mg/5 mL, single-dose fasting

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-07-21

Locations

2 sites across 1 country: United States