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NCT00875966 Clinical Trial

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

Infections Clinical Trial

Official title:
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00875966
Other study ID # AA17045
Secondary ID
Status Completed
Phase Phase 1
First received April 3, 2009
Last updated March 27, 2017
Start date August 2004
Est. completion date October 2004

Study information
Verified date April 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC

• Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer
Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 37 days
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