A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
IMPAX Laboratories, Inc. Impax Laboratories, LLC
Treatments:
Carbidopa Carbidopa, levodopa drug combination Levodopa