Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

An Open-Label Study to Assess the 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