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
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.

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 August 28, 2014