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NCT00869791 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
A Phase 2 study of Parkinson's Disease, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT00869791: Completed Phase 2 study of Parkinson's Disease, sponsored by Impax Laboratories.
NCT00869791 is a Phase 2 study of Parkinson's Disease that has completed, run by Impax Laboratories. The registered enrollment target is 27 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00869791, a Phase 2 study of Parkinson's Disease, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.
Primary Outcome
For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cma
Conditions Studied
Interventions
- DRUG IPX066
- DRUG IR CD-LD
Study Locations (1)
California
- IMPAX Laboratories - Hayward
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00869791 record still lists
NCT00869791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which IPX066 is the first listed.
NCT00869791 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00869791 about?
NCT00869791 is a clinical study titled "A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa". This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.
What is the current status of trial NCT00869791?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2008-11. Estimated completion is 2009-06.
What conditions does trial NCT00869791 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT00869791?
The interventions under investigation include: IPX066 (DRUG), IR CD-LD (DRUG).
Who is sponsoring clinical trial NCT00869791?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00869791 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00869791's enrollment target sits among peer trials
27 114th of 158 higher than 42 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease 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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