Trials / Completed
CompletedNCT00674310
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
Detailed description
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ropinirole Hydrochloride | Restless Leg Syndrome |
Timeline
- Start date
- 2004-02-01
- Primary completion
- 2004-02-01
- Completion
- 2004-02-01
- First posted
- 2008-05-07
- Last updated
- 2018-01-23
Source: ClinicalTrials.gov record NCT00674310. Inclusion in this directory is not an endorsement.