Parkinson's Disease Clinical Trial
Official title:
A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease
This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period,
single-dose crossover study. Approximately 51 qualified immediate-release (IR)
CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing
sequences.
Objectives:
- Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa)
in subjects with advanced Parkinson's disease.
- Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
IPX203 contains two different drugs called levodopa and carbidopa in one capsule.
- levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to
improve the symptoms of your Parkinson's disease.
- carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase
inhibitors'. It helps levodopa work more effectively by slowing the speed at which
levodopa is broken down in your body.
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