A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
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Profile of Pharmacokinetics [ Time Frame: 5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours. ]
Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.
Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam) [ Time Frame: 2 days ]
Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2)
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Layout table for eligibility information
Ages Eligible for Study:
30 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female subjects at least 30 years old;
Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
Body mass index range from 18.0 to 30.0 kg/m2
Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke