NCT00648050

Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg to Verelan® PM Extended-Release Capsules 300 mg

Single-Dose Fasting Bioequivalence Study of Verapamil HCl Extended-Release Capsules (300 mg; Mylan) to Verelan® PM Extended-Release Capsules (300 mg; Schwarz) in Healthy Volunteers Dosed in the Evening

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following evening administration of a single, oral 300 mg (1 x 300 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Verapamil Hydrochloride Extended-Release Capsules, 300 mg	300mg, single dose fasting
DRUG	Verelan® PM Extended-Release Capsules, 300 mg	300mg, single dose fasting

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States