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NCT03007888 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
A Phase 2 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT03007888: Completed Phase 2 study, sponsored by Impax Laboratories.
NCT03007888 is a Phase 2 study that has completed, run by Impax Laboratories. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03007888, a Phase 2 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Interventions
- DRUG Sinemet
- DRUG IPX203
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-11-14 |
| Est. Completion | 2017-08-01 |
| Phase | Phase 2 |
What the finished NCT03007888 record still lists
NCT03007888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Sinemet is the first listed.
NCT03007888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03007888 about?
NCT03007888 is a clinical study titled "A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease". 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...
What is the current status of trial NCT03007888?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2016-11-14. Estimated completion is 2017-08-01.
What interventions are being tested in trial NCT03007888?
The interventions under investigation include: Sinemet (DRUG), IPX203 (DRUG).
Who is sponsoring clinical trial NCT03007888?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03007888's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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