Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00601315
First received: September 20, 2007
Last updated: February 5, 2008
Last verified: February 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014