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NCT02271503 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
A Phase 2 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT02271503 is a Phase 2 study that has completed, run by Impax Laboratories. The registered enrollment target is 26 participants.
The verdict
NCT02271503, a Phase 2 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG CD-LD IR
- DRUG IPX203 180 mg
- DRUG IPX203 270 mg
- DRUG Rytary 195 mg
- DRUG Rytary 145 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02271503
The ClinicalTrials.gov registry entry for NCT02271503 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which CD-LD IR is the first listed.
NCT02271503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02271503 about?
NCT02271503 is a clinical study titled "A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease". 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 pharma...
What is the current status of trial NCT02271503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2015-11. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02271503?
The interventions under investigation include: CD-LD IR (DRUG), IPX203 180 mg (DRUG), IPX203 270 mg (DRUG), Rytary 195 mg (DRUG), Rytary 145 mg (DRUG).
Who is sponsoring clinical trial NCT02271503?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
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