To Evaluate the Effect of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 19, 2025

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
Healthy Male and Female Subjects
Interventions
DRUG

Y-4 tablet

The enrolled subjects will be randomly divided into group AB and group BA, with a total of 10 subjects in each group, all subjects will take one Y-4 tablet (pregabalin 112.5 mg, riluzole 28.125 mg) at each period. Subjects of group AB will take Y-4 tablet under fasted condition in period 1, and take Y-4 tablet under fed condition in period 2. In contrast, subjects of group BA will take Y-4 tablet under fed condition in period 1, and take Y-4 tablet under fasted condition in period 2. There will be 7 days of wash-out between the two periods.

Trial Locations (1)

100000

RECRUITING

Beijing Tiantan Hospital, Capital Medical University Beijing, Beijing

Sponsors
All Listed Sponsors
collaborator

Neurodawn Pharmaceutical Co., Ltd.

INDUSTRY

lead

Beijing Tiantan Hospital

OTHER