drugset / Trial / NCT00830219
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
RandomizedCrossoverOpen-label
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.
Timeline
- Start
- 2004-11
- Primary completion
- 2004-11
- Completion
- 2004-11
Outcome
Met primary endpoint
registry Ratio of the T/R geometric mean x 100 103.53 (90% CI 99.16 to 108.09) NCT00830219 ↗
registry Ratio of the T/R geometric mean x 100 102.3 (90% CI 97.56 to 107.27) NCT00830219 ↗
registry Ratio of the T/R geometric mean x 100 102.54 (90% CI 97.53 to 107.8) NCT00830219 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropinirole | Small molecule | 0.25 mg | — |
Indications
No indication recorded.