CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
Ropinirole HCl 0.25 mg Tablets +1 moredrug
Likely dose
Ropinirole HCl 0.25 mg, single dose (1 × 0.25 mg tablet)AI-extracted
Key inclusion· 4
  • ✓Ages 18 to 45 years
  • ✓BMI 19-30 kg/m² and weight at least 120 lbs
  • ✓Good health with no clinically significant abnormalities at screening
  • ✓Sitting blood pressure at least 100/70 mmHg and pulse at least 60 bpm
Key exclusion· 13
  • ✕Pregnant, lactating, or likely to become pregnant
  • ✕History of allergy or sensitivity to ropinirole or dopamine agonists
  • ✕History of dizziness, lightheadedness, or fainting upon standing
  • ✕Chronic infectious disease, organ dysfunction, hypertension/hypotension, arrhythmia, tachycardia, seizure, or glaucoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00830219
NCT00830219Phase 1Completed
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The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

Teva Pharmaceuticals USA·interventional·Posted Jan 27, 2009·Updated Sep 15, 2009

In Brief

A Phase 1 clinical trial evaluating Ropinirole HCl 0.25 mg Tablets and Requip® 0.25 mg Tablets for Healthy. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2009
Enrollment StartNov 1, 2004
Primary CompletionNov 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, single dose fed

Requip® 0.25 mg Tabletsdrug

1 x 0.25 mg, single dose fed