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

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00865670

First received: March 18, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Purpose

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

Condition	Intervention	Phase
Infection	Drug: Azithromycin Monohydrate 600 mg Tablets Drug: Zithromax (azithromycin dihydrate) 600 mg Tablets	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fed Conditions

Resource links provided by NLM:

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:

Bioequivalence according to US FDA guidelines [ Time Frame: 32 days ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	August 2003
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Azithromycin Monohydrate 600mg Tablets	Drug: Azithromycin Monohydrate 600 mg Tablets
Active Comparator: 2 Zithromax (azithromycin dihydrate)600mg Tablets	Drug: Zithromax (azithromycin dihydrate) 600 mg Tablets

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865670

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Alan S. Marion, M.D.

MDS Pharma Services

More Information

No publications provided

Responsible Party:	Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00865670 History of Changes
Other Study ID Numbers:	AA03414
Study First Received:	March 18, 2009
Last Updated:	March 18, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013