NCT07013773

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

A Randomized, Open-label, Single-dose, Two-period, Crossover Phase I Clinical Trial With Two Parallel Arms Evaluating the Impact of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 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.

Detailed description

This study will be a single-center, open-label, single-dose, randomized, two period, two-way crossover study in which the effect of a high-fat breakfast on the pharmacokinetics of Y-4 tablets will be assessed. A total of 20 subjects will be enrolled in this trial. 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. Subjects will be admitted to the clinical phase 1 research center the day before taking the drug, and fasted for at least 10 hours (overnight fast). Water will be forbidden from 1 hour pre-dose to 2 hours post-dose of investigational drug.

Conditions

• Healthy Male and Female Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-19
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study