Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions

Phase 1

Completed

• Conditions: Infections
• Interventions: Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer; Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC

• Registration Number: NCT00875966
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Status Verified: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• No clinically significant findings on physical exam, medial history or laboratory tests on screening

Exclusion Criteria

• Positive test for HIV or hepatitis B and C
• Treatment for Drug or alcohol abuse
• Any other important criteria in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer	Zithromax (azithromycin for oral suspension) 200mg/5mL
1	Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC	Azithromycin for oral suspension 200mg/5mL

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	37 days