drugset / Trial / NCT07442591
A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants
Phase 1
Recruiting
12 enrolled
Shanghai WD Pharmaceutical Co., Ltd.
BalGenSource Medical Technology Co. Ltd. · collabShanghai BioGuider Medical Technology Co., Ltd. · collabShanghai Xihua Scientific Co., Ltd. · collabShanghai Xuhui Central Hospital · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
WD-1603 contains two different drugs called levodopa and carbidopa in one tablet. The goal of this clinical trial is to see if taking the study drug WD-1603 at different time intervals affects how the drug acts in healthy volunteers. We also want to learn about the safety of WD-1603. The main question we want to answer is: * How does the body process WD-1603 when it is taken by different time intervals? What will participants do? * Participants will take one tablet of WD-1603 twice a day on three separate days. * On each dosing day, the two doses will be spaced different hours apart. * Between each dosing day, there will be a rest period of up to 7 days.
Timeline
- Start
- 2026-03-24
- Primary completion
- 2026-06
- Completion
- 2026-12
Publications
- Background 中华医学会神经病学分会帕金森病及运动障碍学组 and 中国医师协会神经内科医师分会帕金森病及运动障碍学组, 中国帕金森病治疗指南(第四版). 中华神经科杂志, 2020. 53(12): p. 973-986.
- Background Kempster PA, Frankel JP, Bovingdon M, Webster R, Lees AJ, Stern GM. Levodopa peripheral pharmacokinetics and duration of motor response in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1989 Jun;52(6):718-23. doi: 10.1136/jnnp.52.6.718.
- Background Adepu S, Ramakrishna S. Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules. 2021 Sep 29;26(19):5905. doi: 10.3390/molecules26195905.
- Background Buril J, Burilova P, Pokorna A, Kovacova I, Balaz M. Representation of Parkinson's disease and atypical Parkinson's syndromes in the Czech Republic-A nationwide retrospective study. PLoS One. 2021 Feb 2;16(2):e0246342. doi: 10.1371/journal.pone.0246342. eCollection 2021.
- Background Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 25 mg | Oral |
| Subject | Levodopa | Small molecule | 150 mg | Oral |
Indications
No indication recorded.