Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

This study has been completed.

First Received on September 20, 2007. Last Updated on February 5, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601315

Purpose

The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.

Condition	Intervention
Infection	Drug: Clarithromycin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 250 mg Clarithromycin Tablets Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Clarithromycin

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	April 2003
Study Completion Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601315

Locations

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044-5318

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Mark J Allison, MD

MDS Pharma Services

More Information

No publications provided

Responsible Party:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00601315 History of Changes
Other Study ID Numbers:	461-07
Study First Received:	September 20, 2007
Last Updated:	February 5, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

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

ClinicalTrials.gov processed this record on February 09, 2012