NCT00775255

Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension 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/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 Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• 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 that of Abbott Laboratories (Biaxin®) following administration of a 250 mg/5 mL dose in healthy, adult, human, male 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 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension (containing clarithromycin 250 mg/5mL) of Abbott Laboratories in healthy, adult, human, male subjects under fasting conditions. A single oral dose of clarithromycin 250-mg/5 mL was administered during each period of the study under supervision of a trained Medical Officer. During the course of the study safety parameters assessed were vital signs, twelve-lead ECG, clinical examination, medical history, clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at base line and hematology and biochemical parameters at 24 hours post dose of the last period of the study. Twelve-lead ECG was recorded at 4 and 8 hours post-dose in each period. A Validated analytical method was used for the analysis of Clarithromycin in human plasma. Pharmacokinetic and statistical analysis was performed to conclude the bioequivalence.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	clarithromycin 250 mg/5 mL powder for oral suspension

Timeline

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

Locations

1 site across 1 country: India