NCT06935721

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Male and Female Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study