NCT00774189

Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions

An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Clarithromycin Formulations, Comparing Clarithromycin 250 mg Tablets of Ranbaxy Laboratories With Biaxin 250 mg Tablets of Abbott Laboratories in Healthy, Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study was to compare the single-dose oral bioavailability of Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott Laboratories in healthy, adult, human subjects under fasting conditions

Detailed description

This was an open label, balanced, and randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study planned on 32 healthy, adult, human subjects under fasting conditions. 31 subjects completed both the periods of the study. Both periods were separated by a washout of twelve days The study was conducted on 32 healthy, adult, human subjects under fasting conditions. 31 subjects completed both the periods of the study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	clarithromycin 250 mg tablets

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-08-01
• Completion: 2003-11-01
• First posted: 2008-10-17
• Last updated: 2008-10-17

Locations

1 site across 1 country: India