To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions

This study has been completed.

First Received: April 14, 2009 No Changes Posted

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00881855

Purpose

The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.

Condition	Intervention	Phase
Healthy	Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH) Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)	Phase I

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 Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fed Conditions.

Resource links provided by NLM:

Drug Information available for: Cefprozil

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	March 2004
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cefprozil 500 mg Tablets (Sandoz, GmbH)	Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH)
2: Active Comparator Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)	Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)

Eligibility

Criteria

Inclusion Criteria:

No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881855

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Gaetano Morelli, M.D.

MDS Pharma Services

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development )
Study ID Numbers:	AA17501
Study First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881855 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sandoz Inc.:

Antibiotics

Study placed in the following topic categories:

Anti-Infective Agents
Cefprozil
Anti-Bacterial Agents
Malnutrition
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Cefprozil
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2009