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

NCT00239564 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-10-29

No results posted yet for this study

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.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

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

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-12-31
Completion
2007-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00239564 on ClinicalTrials.gov