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RECRUITING
NCT06935682
PHASE1

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

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 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.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Study to Assess the Safety and Pharmacokinetics of Y-4 Tablets After Single- and Multiple-dose in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-01-04

Completion Date

2025-06-30

Last Updated

2025-04-20

Healthy Volunteers

Yes

Interventions

DRUG

Y-4 tables

Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 tablets on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 tablets continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.

DRUG

Y-4 placebos

Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 placebos on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 placebos continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University Beijing

Beijing, Beijing Municipality, China