NCT00648622

Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg

Single-Dose Food In Vivo Bioequivalence Study of Carvedilol Tablets (12.5 mg; Mylan) to Coreg® Tablets (12.5 mg; GSK) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Carvedilol Tablets 12.5 mg	12.5mg, single dose fed
DRUG	Coreg® Tablets 12.5 mg	12.5mg, single dose fed

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States