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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00875966
First received: April 3, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D., VP Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00875966     History of Changes
Other Study ID Numbers: AA17045
Study First Received: April 3, 2009
Last Updated: April 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014