To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

This study has been completed.

First Received: April 13, 2009 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00881179

Purpose

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA) Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)	Phase I

Drug Information available for: Clarithromycin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	May 2002
Study Completion Date:	June 2002
Primary Completion Date:	June 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)	Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
2: Active Comparator Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)	Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, 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: NCT00881179

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

So Ran Hong, M.D.

Novum Pharmaceutical Research Services

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development )
Study ID Numbers:	B013721
Study First Received:	April 13, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00881179 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sandoz Inc.:

Antibiotic

Study placed in the following topic categories:

Clarithromycin
Anti-Bacterial Agents
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Clarithromycin

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009