Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-23 @ 12:40 PM
Study NCT ID:
NCT03733561
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2018-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro
Sponsor:
Luye Pharma Group Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1, single center study to assess pharmacokinetic profiles of rotigotine after single dose of LY03003 and daily patch application of Neupro in Healthy Volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: