NCT00829504

Ropinirole 0.25 mg Tablets Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, 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
DRUG	Requip® 0.25 mg Tablets	1 x 0.25 mg

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2009-01-27
• Last updated: 2009-09-11
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States