drugset / Trial / NCT00829504
Ropinirole 0.25 mg Tablets Under Fasting Conditions
RandomizedCrossoverOpen-label
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.
Timeline
- Start
- 2004-10
- Primary completion
- 2004-10
- Completion
- 2004-10
Outcome
Met primary endpoint
registry Ratio of the T/R geometric mean x 100 100.16 (90% CI 95.5 to 105.04) NCT00829504 ↗
registry Ratio of the T/R geometric mean x 100 101.76 (90% CI 95.45 to 108.49) NCT00829504 ↗
registry Ratio of the T/R geometric mean x 100 102.1 (90% CI 95.64 to 109) NCT00829504 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropinirole | Small molecule | 0.25 mg | — |
Indications
No indication recorded.