NCT00864149

A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Non-fasting Conditions

A Two-Way Crossover, Open-Label, Single Dose, Fed, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.

Detailed description

Study Type: Interventional Study Design: Two-way crossover, randomized, open-label, single-dose, fed, bioequivalence study Official Title: A Two-Way Crossover, Open-Label, Single Dose, Fed, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Carvedilol 12.5 mg Tablets, single dose	A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions
DRUG	Coreg® 12.5 mg Tablets , single dose	B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fed conditions

Timeline

• Start date: 2005-10-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2009-03-18
• Last updated: 2010-08-16

Locations

1 site across 1 country: Canada