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

This study has been completed.

First Received: March 18, 2009 Last Updated: March 19, 2009 History of Changes

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00866216

Purpose

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

Condition	Intervention	Phase
Infection	Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.	Phase I

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

Resource links provided by NLM:

Drug Information available for: Azithromycin

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ 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
1: Experimental Azithromycin Monohydrate 600mg Tablets	Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals
2: Active Comparator Zithromax (Azithromycin Dihydrate) 600mg Tablets	Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Eligibility

Criteria

Inclusion Criteria:

No clinically significant abnormal findings 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: NCT00866216

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Alan S Marion

MDS Pharma

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D., VP Product Development )
Study ID Numbers:	AA02511
Study First Received:	March 18, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866216 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Azithromycin
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses

Azithromycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2009