NCT00279825

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

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 200 mg	IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
DRUG	IPX054 250 mg	IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
DRUG	CD-LD IR	Active comparator containing 25 mg carbidopa and 100 mg levodopa
DRUG	CD-LD CR	Active comparator containing 50 mg carbidopa and 200 mg levodopa
DRUG	IPX054 200 mg Placebo	Placebo to match IPX054 200 mg
DRUG	IPX054 250 mg Placebo	Placebo to match IPX054 250 mg
DRUG	CD-LD IR Placebo	Placebo to match CD-LD IR
DRUG	CD-LD CR Placebo	Placebo to match CD-LD CR

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-01-20
• Last updated: 2019-10-29

Locations

2 sites across 1 country: United States