Parkinson's Disease Clinical Trial
Official title:
Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease
This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.
The study duration includes a screening period followed by an overnight stay in the center (4
days, 3 nights) to complete 2 treatments, including a 48-hour interval between the
treatments, and a follow-up phone call 1-2 days after discharge from the center.
On each of two treatment days, subjects will consume a standard high fat meal and then
receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD
followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such
that each subject receives both Treatment A and Treatment B over the 2 treatment days,
randomized 1:1 to the treatment sequence AB or BA.
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