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Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

NCT06935682 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

  • Healthy Adult Male and Female Volunteers

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.

Sponsors & Collaborators

  • Neurodawn Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-04
Primary Completion
2025-05-04
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935682 on ClinicalTrials.gov