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RECRUITING
NCT06935721
PHASE1

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The objective of the trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules (Lyrica®) and riluzole tablets (Rilutek®) in Chinese healthy adult subjects after single oral administration under fasted condition.

Official title: An Open-label, Single-dose, Three-period Phase 1 Study to Compare the Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Healthy Subjects Under Fasted Condition

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-03-28

Completion Date

2025-06

Last Updated

2025-04-20

Healthy Volunteers

Yes

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.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University Beijing

Beijing, Beijing Municipality, China