Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose. The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.

NCT Number	NCT06935682
Lead Sponsor	Beijing Tiantan Hospital Collaborators: Neurodawn Pharmaceutical Co., Ltd.
Conditions	Healthy Adult Male and Female Volunteers
Enrollment	36 participants
Start Date	2025-01-04
Primary Completion	2025-05-04 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-20