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

NCT ID: NCT00239564

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: carbidopa and 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.

Group Type: EXPERIMENTAL

IPX054 100 mg

Intervention Type: DRUG

IPX054 containing 25 mg carbidopa and 100 mg levodopa

IPX054 150 mg

Intervention Type: DRUG

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

IPX054 200 mg

Intervention Type: DRUG

CD-LD CR containing 50 mg carbidopa and 200 mg levodopa

IPX054 250 mg

Intervention Type: DRUG

CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa

IPX054 300 mg

Intervention Type: DRUG

CD-LD CR containing 75 mg carbidopa and 300 mg levodopa

Interventions

IPX054 100 mg

IPX054 containing 25 mg carbidopa and 100 mg levodopa

Intervention Type: DRUG

IPX054 150 mg

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

Intervention Type: DRUG

IPX054 200 mg

CD-LD CR containing 50 mg carbidopa and 200 mg levodopa

Intervention Type: DRUG

IPX054 250 mg

CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa

Intervention Type: DRUG

IPX054 300 mg

CD-LD CR containing 75 mg carbidopa and 300 mg levodopa

Intervention Type: DRUG

Other Intervention Names

CD-LD ER 100 mg; CD-LD ER 150 mg; CD-LD ER 200 mg; CD-LD ER 250 mg; CD-LD ER 300 mg

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Impax Laboratories, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Impax Study Director

Role: STUDY_DIRECTOR

Impax Laboratories, LLC

Locations

Site 101

Sunnyvale, California, United States

Site 102

Lawrence, Kansas, United States

Countries

United States

Other Identifiers

IPX054-B04-06

Identifier Type: -

Identifier Source: org_study_id