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

Phase 1 Recruiting 20 enrolled Beijing Tiantan Hospital Neurodawn Pharmaceutical Co., Ltd. · collab

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2025-05-19
Primary completion: 2025-07
Completion: 2025-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	112.5 mg	Oral
Subject	Riluzole	Small molecule	28.125 mg	Oral

Indications

No indication recorded.