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NCT04384666 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers
A Phase 1 study, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT04384666 is a Phase 1 study that has completed, run by Luye Pharma Group. The registered enrollment target is 56 participants.
The verdict
NCT04384666, a Phase 1 study, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment sequences.
Interventions
- DRUG LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)
- OTHER Neupro 4 mg / 24 Hr. Transdermal Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-06-02 |
| Est. Completion | 2020-08-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04384666
The ClinicalTrials.gov registry entry for NCT04384666 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Luye Pharma Group, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) is the first listed.
NCT04384666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04384666 about?
NCT04384666 is a clinical study titled "A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers". This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment seq...
What is the current status of trial NCT04384666?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-06-02. Estimated completion is 2020-08-10.
What interventions are being tested in trial NCT04384666?
The interventions under investigation include: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) (DRUG), Neupro 4 mg / 24 Hr. Transdermal Patch (OTHER).
Who is sponsoring clinical trial NCT04384666?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
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