Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of
 IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa
 controlled-release tablets in subjects with idiopathic Parkinson's disease.
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:

 -  Diagnosed with idiopathic Parkinson's disease.

 -  Currently being treated with immediate-release or controlled-release
 carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.

 -  Must experience "wearing OFF" between doses of medication.

 Exclusion Criteria:

 -  Diagnosed with atypical parkinsonism.

 -  Allergic or non-responsive to previous carbidopa-levodopa therapy.

 -  Active or history of narrow-angle or wide-angle glaucoma.

 -  History of seizure or epilepsy, or is currently taking an anti-convulsant for
 treatment of seizures.

 -  Treatment with any neuroleptic agent, including atypical neuroleptics, within the
 previous 12 months.

 -  Treatment with any dopaminergic blocking agent within the previous 3 months.