Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Infection
• Interventions: Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals; Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

• Registration Number: NCT00866216
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

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: 2009-03-19
• Study First Posted: 2009-03-20
• 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 findings 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 600mg Tablets Geneva Pharmaceuticals	Azithromycin Monohydrate 600mg Tablets
2	Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.	Zithromax (Azithromycin Dihydrate) 600mg Tablets

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	32 days