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The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR after single and multiple doses of the PR-formulation. It will also investigate the safety and tolerability of ropinirole PR after single and multiple doses of PR-formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving ropinirole | Experimental | Eligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole | Drug | Ropinirole 2 milligrams once daily prolonged release tablet will be given at 24-hour intervals in the morning. Single and repeat dose treatment periods will be separated by 7 days of washout period. |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Pharmacokinetics | Cmax, AUC (0-24), AUC(0-inf) | predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24,36,48,72, 96,120,144,168 hours post-dose |
| Profile of Pharmacokinetics | Css_max, Css_min and AUCss | predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Pharmacokinetics | Tmax, T1/2, Kel | pre-dose,1,2,3,4,6,8,10,12,14,16,18,20,22, 24,36,48,72,96,120,144,168hours post-dose |
| Composition of Pharmacokinetics | Tmax, Css_av, DF,accumulation ratios (Ro and Rs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beijing | 100032 | China |
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| Label | URL |
|---|---|
| Results for study 112558 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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| predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |