This study in PD 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 three 4mg ropinirole tablets versus one 12mg tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
George, Eastern Cape, South Africa
Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours
Time frame: 24 hours
Time to attain the maximum plasma concentration Incidence of adverse events over 37 days As above, but for ropinirole metabolites
Time frame: over 37 days
Vital signs, ECG and clinical laboratory data over 37 days
Time frame: over 37 days
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