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Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

NCT00279825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-10-29

No results posted yet for this study

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.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

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

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

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 NCT00279825 on ClinicalTrials.gov