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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00829504 |
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.
Condition | Intervention | Phase |
---|---|---|
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 Fasting Conditions. |
Enrollment: | 44 |
Study Start Date: | October 2004 |
Study Completion Date: | October 2004 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Ropinirole HCl 0.25 mg Tablets
1 x 0.25 mg
|
2: Active Comparator |
Drug: Requip® 0.25 mg Tablets
1 x 0.25 mg
|
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, G1V 2K8 |
Principal Investigator: | Soran Hong, M.D. | Novum Pharmaceuticals Research Services |
Study ID Numbers: | 10436008 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00829504 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Neurotransmitter Agents Ropinirole Dopamine |
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 |