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
PhasePhase 1/Phase 2
Lead SponsorImpax Laboratories
StatusCompleted No Results Posted
Indication/ConditionIdiopathic 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.
IPX054 containing 25 mg carbidopa and 100 mg levodopa
IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
CD-LD CR containing 75 mg carbidopa and 300 mg levodopa
Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.
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