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Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06935721•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.

Detailed Description

This study will be an open-label, single-dose, three-period study in healthy adult subjects. A total of 10 subjects (half men and half women) will be enrolled in this study to be administered with Y-4 tablets, pregabalin capsules and riluzole tablets at three periods with a 7-day washout. Periods and corresponding treatments are planned as following: Period 1: Y-4 tablet, one tablet, 112.5 mg/28.125 mg (pregabalin/riluzole) Period 2: pregabalin capsule, one capsule, 75 mg/capsule Period 3: riluzole tablet, one tablet, 50 mg/tablet

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adult male and female subjects, 18-45 years of age (including both ends).
•2. Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
•3. During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female subject, according to the calculation result × 0.85）.
•4. Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.

Exclusion Criteria

•1. Subjects who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, Copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry amb Ⅱ), have allergic diseases or allergic constitution;
•2. Subjects who have special requirements for diet and cannot follow the unified diet;
•3. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
•4. Subjects who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
•5. History of dizziness or vertigo with clinical significance, or disease of inner ear known to cause dizziness or vertigo;
•6. QTcF \> 450 msec at the screening stage;
•7. Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other serious mental disorders, and principal investigator determines that the subject is not suitable to participate in this trial;
•8. Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;
•9. Subjects who drink too much tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, or disagree that any caffeine-containing beverages are prohibited during the trial;
•10. Subjects who have consume any diet (food or beverage) rich in grapefruit, pitaya, mango and cranberry within 14 days prior to screening;
+14 more criteria

Locations (1)

Beijing Tiantan Hospital, Capital Medical University Beijing

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 28, 2025

Primary Completion Date

May 1, 2025

Completion Date

June 1, 2025

Last Updated

April 20, 2025

Enrollment

ESTIMATED participants

Conditions

Healthy Male and Female Subjects

Interventions

Y-4 tablet

DRUG

Pregabalin capsule

DRUG

Riluzole tablet

DRUG

Contacts

Ya Shu Li

CONTACT

+010-59978555 shuyali85@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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