To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions

Phase 1

Completed

• Conditions: Infection
• Interventions: Drug: Azithromycin Monohydrate 600 mg Tablets; Drug: Zithromax (azithromycin dihydrate) 600 mg Tablets

• Registration Number: NCT00865670
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2009-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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
• Female subjects who are pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Azithromycin Monohydrate 600 mg Tablets	Azithromycin Monohydrate 600mg Tablets
2	Zithromax (azithromycin dihydrate) 600 mg Tablets	Zithromax (azithromycin dihydrate)600mg Tablets

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA guidelines	32 days