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To Evaluate the Effect of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects

NCT07013773 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-10

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 is to assess the effect of food on the pharmacokinetics (PK) of pregabalin and riluzole in healthy adult subjects after a single oral dose of Y-4 tablets.

Conditions

  • Healthy Male and Female Subjects

Interventions

DRUG

Y-4 tablet

The enrolled subjects will be randomly divided into group AB and group BA, with a total of 10 subjects in each group, all subjects will take one Y-4 tablet (pregabalin 112.5 mg, riluzole 28.125 mg) at each period. Subjects of group AB will take Y-4 tablet under fasted condition in period 1, and take Y-4 tablet under fed condition in period 2. In contrast, subjects of group BA will take Y-4 tablet under fed condition in period 1, and take Y-4 tablet under fasted condition in period 2. There will be 7 days of wash-out between the two periods.

Sponsors & Collaborators

  • Neurodawn Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2025-07-31
Completion
2025-07-31
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 NCT07013773 on ClinicalTrials.gov