Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Roxane Laboratories

Status: Completed

Conditions: Infection

Treatments: Drug: Clarithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601315

461-07

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)