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

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00875966

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 I

Drug Information available for: Azithromycin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

Further study details as provided by Sandoz Inc.:

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
1: Experimental Azithromycin for oral suspension 200mg/5mL	Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
2: Active Comparator 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

Criteria

Inclusion Criteria:

No clinically significant findings on physical exam, medial history or laboratory tests on screening

Exclusion Criteria:

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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

Study placed in the following topic categories:

Anti-Bacterial Agents
Malnutrition
Azithromycin
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses

Azithromycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009