NCT00979537

Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (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 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nisoldipine Extended-release Tablets, 40 mg
DRUG	Sular Tablets, 40 mg

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2009-09-18
• Last updated: 2009-09-18

Locations

1 site across 1 country: United States