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

NCT06935721 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

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 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.

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.

Sponsors & Collaborators

  • Neurodawn Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2025-05-31
Completion
2025-06-30
FDA Drug
Yes

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 NCT06935721 on ClinicalTrials.gov