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A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

NCT02271503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-11-06

No results posted yet for this study

Summary

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences.

Objectives:

* Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.
* Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.

Conditions

Interventions

DRUG

CD-LD IR

CD-LD IR containing 25 mg carbidopa and 100 mg levodopa

DRUG

IPX203 180 mg

IPX203 containing 45 mg carbidopa and180 mg levodopa

DRUG

IPX203 270 mg

IPX203 containing 67.5 mg carbidopa and 270 mg levodopa

DRUG

Rytary 195 mg

Rytary 48.75Mg-195Mg Extended-Release Capsule

DRUG

Rytary 145 mg

Rytary 36.25Mg-145Mg Extended-Release Capsule

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-08-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02271503 on ClinicalTrials.gov