To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fasting Conditions

This study has been completed.

First Received: April 15, 2009 No Changes Posted

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00882700

Purpose

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Cefdinir 300 mg Capsule (Sandoz, Austria) Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)	Phase I

Drug Information available for: Cefdinir

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment
Official Title:	A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fasting State

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment:	28
Study Start Date:	April 2005
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cefdinir 300 mg Capsule (Sandoz, Austria)	Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)
2: Active Comparator Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)	Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, 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: NCT00882700

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Richard Larouche, M.D.

SFBC Anapharm

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development )
Study ID Numbers:	50038
Study First Received:	April 15, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00882700 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sandoz Inc.:

Antibiotic

Study placed in the following topic categories:

Cephalosporins
Anti-Bacterial Agents
Cefdinir
Cefixime
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Cephalosporins

Therapeutic Uses
Cefdinir
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009