NCT02271503

A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease. * Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.

Detailed description

IPX203 contains two different drugs called levodopa and carbidopa in one capsule. * 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	CD-LD IR	CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
DRUG	IPX203 180 mg	IPX203 containing 45 mg carbidopa and180 mg levodopa
DRUG	IPX203 270 mg	IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
DRUG	Rytary 195 mg	Rytary 48.75Mg-195Mg Extended-Release Capsule
DRUG	Rytary 145 mg	Rytary 36.25Mg-145Mg Extended-Release Capsule

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-10-22
• Last updated: 2019-11-06

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study