Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet 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.