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This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence WAXBYZCDE | Experimental | Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), C: 1 x 6 mg CR-RLS (fasted), D: 1 x 6 mg CR-RLS (high fat fed) and E: 2 x 3 mg CR-RLS (fasted). |
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| Sequence WAXBYZCED | Experimental | Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), C: 1 x 6 mg CR-RLS (fasted), E: 2 x 3 mg CR-RLS (fasted) and D: 1 x 6 mg CR-RLS (high fat fed). |
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| Sequence WAXBYZDCE | Experimental | Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), D: 1 x 6 mg CR-RLS (high fat fed), C: 1 x 6 mg CR-RLS (fasted) and E: 2 x 3 mg CR-RLS (fasted). |
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| Sequence WAXBYZDEC | Experimental | Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), D: 1 x 6 mg CR-RLS (high fat fed), E: 2 x 3 mg CR-RLS (fasted) and C: 1 x 6 mg CR-RLS (fasted). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole | Drug | Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51. |
| Measure | Description | Time Frame |
|---|---|---|
| Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration | dosing interval |
| Measure | Description | Time Frame |
|---|---|---|
| Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites | Time taken for ropinirole concentration to fall to half initial value |
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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 | Berlin | 14050 | Germany | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study ROR106470 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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|
| Sequence WAXBYZECD | Experimental | Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), E: 2 x 3 mg CR-RLS (fasted),C: 1 x 6 mg CR-RLS (fasted) and D: 1 x 6 mg CR-RLS (high fat fed). |
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| Sequence WAXBYZEDC | Experimental | Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), E: 2 x 3 mg CR-RLS (fasted), D: 1 x 6 mg CR-RLS (high fat fed) and C: 1 x 6 mg CR-RLS (fasted). |
|
| George |
| 6530 |
| South Africa |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |