NCT00730197

Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg

Single-Dose Fasting 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: 48 (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 fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Albuterol Sulfate Extended-Release Tablets 8 mg	8mg, single dose fed
DRUG	VoSpire® ER Tablets 8 mg	8mg, single dose fed

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2008-08-08
• Last updated: 2008-08-08

Locations

1 site across 1 country: United States