NCT00775372

Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions

An Open Label, Balanced, Randomised, Two-Treatment, Four-Period, Two- Sequence, Single-Dose, Crossover Fully Replicated, Bioavailability Study on Clarithromycin Formulations Comparing Clarithromycin 250 mg/5 mL Powder for Oral Suspension of Ranbaxy Laboratories With Biaxin® Granules 250 mg/5 mL Oral Suspension in Healthy, Adult,Human, Male Subjects Under Fed Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in healthy, adult, human, male subjects under fed conditions

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, four-period, two-sequence, single-dose, crossover fully replicated, bioavailability study on clarithromycin formulations comparing clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension in healthy, adult, human, male subjects under fed conditions A single oral dose of clarithromycin 250 mg/5 mL 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 250mg/5mL

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-10-01
• Completion: 2005-12-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: India