To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb); Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)

• Registration Number: NCT00881426
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)	Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
1	Cefprozil 500 mg Tablets (Sandoz GmbH)	Cefprozil 500 mg Tablets (Sandoz GmbH)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	16 days