drugset / Trial / NCT03007888

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

NCT03007888

Phase 2 Completed 28 enrolled Impax Laboratories, LLC
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject IPX203 Unknown
Subject Levodopa Small molecule

Indications