MedTrace Logo

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

NCT03007888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-06-06

Study results available
· View outcomes & findings →

Summary

Primary Objective:

To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

Secondary Objectives:

To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

To evaluate the safety of IPX203.

Conditions

  • Advanced Parkinson's Disease

Interventions

DRUG

Sinemet

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

DRUG

IPX203

Extended Release capsules containing carbidopa-levodopa flexible dosing

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • United States

Study Locations

More Related Trials

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 NCT03007888 on ClinicalTrials.gov