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

Phase 1 Recruiting 10 enrolled Beijing Tiantan Hospital Neurodawn Pharmaceutical Co., Ltd. · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2025-03-28
Primary completion: 2025-05
Completion: 2025-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	75 mg	Oral
Subject	Riluzole	Small molecule	50 mg	Oral
Subject	Y-4	Unknown	—	Oral

Indications

No indication recorded.