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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00830219 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: Ropinirole HCl 0.25 mg Tablets Drug: Requip® 0.25 mg Tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions |
Enrollment: | 46 |
Study Start Date: | November 2004 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Ropinirole HCl 0.25 mg Tablets
1 x 0.25 mg, single dose fed
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2: Active Comparator |
Drug: Requip® 0.25 mg Tablets
1 x 0.25 mg, single dose fed
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Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 | |
Canada, Quebec | |
SFBC Anapharm | |
Sainte-Foy, Quebec, Canada, G1V2K8 |
Principal Investigator: | So Ran Hong, M.D. | Novum Pharmaceutical Research Services |
Study ID Numbers: | 10436009 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830219 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Neurotransmitter Agents Ropinirole Dopamine Malnutrition |
Dopamine Agents Healthy Dopamine Agonists |
Neurotransmitter Agents Ropinirole Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs |
Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |