NCT00649805

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

Single-Dose Fasting Bioequivalence Study of Verapamil HCl Extended-Release Capsules (300 mg;Mylan) and Verelan® PM Extended-Release Capsules (300 mg; Schwarz) Sprinkled on Applesauce in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following by a single, oral 300 mg (1 x 300 mg) dose administration sprinkled on one tablespoon of applesauce under fasting conditions.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-01-01
• Completion: 2006-02-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States