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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239564

Enrollment

Registered

2005-10-17

Start date

2005-10-31

Completion date

2007-12-31

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson's Disease

Keywords

IPX054, Parkinson disease, Levodopa

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.

Interventions

DRUGIPX054 100 mg

IPX054 containing 25 mg carbidopa and 100 mg levodopa

DRUGIPX054 150 mg

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

DRUGIPX054 200 mg

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

DRUGIPX054 250 mg

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

DRUGIPX054 300 mg

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Parkinsonian disability at Visits 1 and 5	36 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026