At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 44 enrolled
Drug / intervention
Ropinirole HCl 0.25 mg Tablets +1 moredrug
Likely dose
Ropinirole HCl 0.25 mg Tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Ropinirole HCl 0.25 mg Tablets and Requip® 0.25 mg Tablets for Healthy. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
Primary CompletionOct 2004
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartOct 1, 2004
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Ropinirole HCl 0.25 mg Tabletsdrug
1 x 0.25 mg
Requip® 0.25 mg Tabletsdrug
1 x 0.25 mg