Overview

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

Status:
RECRUITING
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE1
Details
Lead Sponsor:
Beijing Tiantan Hospital
Collaborator:
Neurodawn Pharmaceutical Co., Ltd.