NCT00774644

Bioequivalence Study of Clarithromycin 500mg Tablets Under 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 Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• 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 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 fasting conditions Eligible subjects underwent pre-study examinations that included a physical examination, 12-lead ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis Ci HIV), and urine drugs of abuse. Laboratory testing for female subjects also included a serum pregnancy test.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clarithromycin 500mg

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-01-01
• Completion: 2003-02-01
• First posted: 2008-10-17
• Last updated: 2008-11-18

Locations

1 site across 1 country: United States