Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Clarithromycin

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.