NCT00776113

Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions

An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Carvedilol Formulations Comparing Carvedilol 12.5 mg Tablets of Ranbaxy Laboratories With Coreg® 12.5 mg Tablets of Glaxosmithkline in Healthy, Adult, Human 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

The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ohm Laboratories with Coreg 12.5 mg tablets in healthy, adult, human subjects under fasting conditions.

Detailed description

The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study on carvedilol formulation comparing carvedilol 12.5mg of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc, USA) with Coreg® 12.5mg tablet (containing carvedilol 12.5 mg) of GlaxoSmithKline, USA in healthy, adult, male, human subjects under fasting condition. Forty healthy, adult, human subjects who met the inclusion and exclusion criteria as described in the protocol were enrolled in the study. Thirty-six subjects completed both the periods of the study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Carvedilol 12.5 mg tablets	bioequivalence Carvedilol fasting

Timeline

• Start date: 2003-08-01
• Primary completion: 2003-09-01
• Completion: 2003-12-01
• First posted: 2008-10-20
• Last updated: 2008-10-20