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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: April 3, 2009
Last updated: March 27, 2017
Last verified: April 2009
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

Condition Intervention Phase
Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 37 days ]

Enrollment: 42
Study Start Date: August 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Azithromycin for oral suspension 200mg/5mL
Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
Active Comparator: 2
Zithromax (azithromycin for oral suspension) 200mg/5mL
Drug: 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Eric Mittleberg, Ph.D., VP Product Development, Sandoz Inc. Identifier: NCT00875966     History of Changes
Other Study ID Numbers: AA17045
Study First Received: April 3, 2009
Last Updated: March 27, 2017

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 23, 2017