NCT00774696

Bioequivalence Study of Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

The Objective of This Study is to Compare the Relative Bioavailability of Clarithromycin 500 mg Tablets (Ranbaxy Laboratories Limited) With That of BIAXIN® 500 mg Tablets in Healthy, Adult Subjects Under Non-Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under non-fasting conditions.

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioavailability study on clarithromycin formulations comparing clarithromycin 500mg tablets of Ranbaxy Laboratories with Biaxin® tablets 500mg (containing clarithromycin 500 mg)in healthy, adult, human, male subjects under fed conditions Subjects were given a standardized meal starting 30 minutes before their assigned dosing time consisting of one buttered English muffin, one fried egg, one slice of American cheese, one slice of Canadian bacon, 2.45 ounces of hash brown potatoes, six fluid ounces of orange juice, and eight fluid ounces of whole milk. A single oral dose of clarithromycin 500mg was administered during each period under supervision of a trained Medical Officer. During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology \& biochemical parameters) were performed again at the end of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	clarithromycin 500mg tablets

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2003-02-01
• First posted: 2008-10-17
• Last updated: 2008-10-17

Locations

1 site across 1 country: United States