Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and
 carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease
 who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release
 tablets.
IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

 -  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.
Inclusion Criteria:

 -  Clinical diagnosis of idiopathic Parkinson's disease

 -  Currently being treated with a stable dosage regimen of immediate-release
 carbidopa-levodopa for at least 3 months.

 -  Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at
 least 2 hours of "OFF" time per day.

 Exclusion Criteria:

 -  Diagnosed with atypical parkinsonism

 -  Prior surgical interventions for Parkinson's disease

 -  Glaucoma

 -  Undiagnosed skin lesion or history of melanoma

 -  Epilepsy or history of seizures