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Clinical Trial 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.


Clinical Trial Description

IPX203 is an investigational product containing CD‑LD.

IPX203-B16-01 Study Design:

A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2‑period, multiple-dose crossover study.

Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

The study duration will be approximately 8 weeks, including the screening period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03007888
Study type Interventional
Source Impax Laboratories, LLC
Contact
Status Completed
Phase Phase 2
Start date November 14, 2016
Completion date August 1, 2017

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