drugset / Trial / NCT04384666

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

NCT04384666

Phase 1 Completed 56 enrolled Luye Pharma Group Ltd.
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2020-06-02
Primary completion
2020-08-05
Completion
2020-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject LY03003 Unknown 28 mg Intramuscular

Indications