Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07013773
PHASE1

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

Sponsor: 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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-19

Completion Date

2025-07

Last Updated

2025-06-10

Healthy Volunteers

Yes

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.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University Beijing

Beijing, Beijing Municipality, China