To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria); Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)

• Registration Number: NCT00881400
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-06
• Study Completion: 2004-06
• 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: 24

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)	Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)
2	Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)	Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	15 days