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drugset / Trial / NCT06935682

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

NCT06935682 ↗

Phase 1 Recruiting 36 enrolled Beijing Tiantan Hospital Neurodawn Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose. The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.

Timeline

Start
2025-01-04
Primary completion
2025-05-04
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 75 mg Oral
Subject Pregabalin Small molecule 112.5 mg Oral
Subject Pregabalin Small molecule 150 mg Oral
Subject Riluzole Small molecule 18.75 mg Oral
Subject Riluzole Small molecule 28.125 mg Oral
Subject Riluzole Small molecule 37.5 mg Oral

Indications

No indication recorded.