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Safety, Tolerability and Pharmacokinetics of Y-2(Edaravone And Borneol) Sublingual Tablet

Stroke, Acute Clinical Trial

Official title:
Sublingual Y-2(Edaravone And Borneol) Tablet For Acute Ischemic And Hemorrhagic Patients-the SALVAGE Trial

Clinical Trial Summary

The primary objective is to evaluate the safety and tolerability of single ascending dose of Y-2 sublingual tablets in healthy male and female adult subjects. The secondary objective is to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male and female adult subjects.

Clinical Trial Description

This study will be a single-center, single ascending dose study in healthy male and female subjects. A total of 24 subjects, 4 cohorts of 6 subjects each, will be enrolled in this study. All of the 6 subjects in each cohort will receive a single dose of Y-2 sublingual tablet on a single occasion. Prior to taking the drug and after taking the drug at 5 min to 24 h, venous blood from all subjects will be collected at different time points for PK analysis. After dosing, safety and tolerability data for each cohort will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03495206
Study type Interventional
Source Yantai YenePharma Co., Ltd.
Contact David Z. Wang, M.D.
Phone (309) 624-9500
Email david.wang@chinastroke.net
Status Recruiting
Phase Phase 1
Start date October 25, 2018
Completion date February 2021
View Details
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