drugset / Trial / NCT02271503
A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2015-11
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 25 mg | — |
| Subject | Carbidopa | Unknown | 36.25 mg | — |
| Subject | Carbidopa | Unknown | 45 mg | — |
| Subject | Carbidopa | Unknown | 48.75 mg | — |
| Subject | Carbidopa | Unknown | 67.5 mg | — |
| Subject | Levodopa | Unknown | 100 mg | — |
| Subject | Levodopa | Unknown | 145 mg | — |
| Subject | Levodopa | Unknown | 180 mg | — |
| Subject | Levodopa | Unknown | 195 mg | — |
| Subject | Levodopa | Unknown | 270 mg | — |