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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.

Condition Intervention Phase
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:

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


Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • No clinically significant abnormal finding 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00865670

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: Alan S. Marion, M.D. MDS Pharma Services
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. 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:
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2016