NCT00830219

The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ropinirole HCl 0.25 mg Tablets	1 x 0.25 mg, single dose fed
DRUG	Requip® 0.25 mg Tablets	1 x 0.25 mg, single dose fed

Timeline

• Start date: 2004-11-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2009-01-27
• Last updated: 2009-09-15
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States