Official Title: “A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 250 mg Clarithromycin Tablets Under Fasting Conditions”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: May 2003

Intervention(s) in this Clinical Trial

• Drug: Clarithromycin

Primary Measures

• Bioequivalence
  • Time Frame: Baseline, Two period, Seven day washout
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Roxane Laboratories

Overall Clinical Trial Officials and Contacts

Mark J Allison, MD Principal Investigator MDS Pharma Services  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00601315

Study ID Number: 461-07

ClinicalTrials.gov Identifier: NCT00601315

Health Authority: United States: Food and Drug Administration