Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 28, 2025

Primary Completion Date

May 31, 2025

Study Completion Date

June 30, 2025

Conditions
Healthy Male and Female Subjects
Interventions
DRUG

Y-4 tablet

Subjects will be admitted to research center in the afternoon of Day-1 prior to the dosing day and fasting for the next 10 hours overnight. In the morning of the following day (Day 1), subjects will be administered with one tablet of Y-4 , then subjects will be monitored and blood samples will be collected for the following 72 hours. Subjects will be discharged on Day 4.

DRUG

Pregabalin capsule

Subjects will be admitted to research center in the afternoon of Day 7 prior to the dosing day and fasting for the next 10 hours overnight. In the morning of the following day (Day 8), subjects will be administered with one pregabalin capsule , then subjects will be monitored and blood samples will be collected for the following 72 hours. Subjects will be discharged on Day 11.

DRUG

Riluzole tablet

Subjects will be admitted to research center in the afternoon of Day 14 prior to the dosing day and fasting for the next 10 hours overnight. In the morning of the following day (Day 15), subjects will be administered with one riluzole tablet, then subjects will be monitored and blood samples will be collected for the following 72 hours. Subjects will be discharged on Day 18 after safety evaluation.

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