NCT00239564

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	IPX054 100 mg	IPX054 containing 25 mg carbidopa and 100 mg levodopa
DRUG	IPX054 150 mg	IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
DRUG	IPX054 200 mg	CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
DRUG	IPX054 250 mg	CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
DRUG	IPX054 300 mg	CD-LD CR containing 75 mg carbidopa and 300 mg levodopa

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-10-17
• Last updated: 2019-10-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study