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

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ClinicalTrials.gov Identifier: NCT00875966
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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 Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions
Study Start Date : August 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

Responsible Party: Eric Mittleberg, Ph.D., VP Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00875966     History of Changes
Other Study ID Numbers: AA17045
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: April 2009

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