NCT00985660

Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg

Single-Dose Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets (30 mg; Mylan) and Sular® Extended Release Tablets (30 mg; First Horizon) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (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 nisoldipine extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg tablet) dose administration in healthy adult subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nisoldipine Extended-release Tablets, 30 mg	1 x 30 mg Tablet under fasting conditions
DRUG	Sular® Extended Release Tablets, 30 mg	1 x 30 mg Tablet under fasting conditions

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2009-09-28
• Last updated: 2009-09-28

Locations

1 site across 1 country: United States