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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: March 27, 2017
Last verified: March 2009
  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: None (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 ]

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

Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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 27, 2017

Additional relevant MeSH terms:
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017