NCT03495206

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Yantai YenePharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Stroke, Acute
• Intracranial Hemorrhages

Interventions

Type	Name	Description
DRUG	Y-2(Edaravone And Borneol) Sublingual Tablet	Y-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets

Timeline

• Start date: 2018-10-25
• Primary completion: 2020-12-01
• Completion: 2021-02-01
• First posted: 2018-04-11
• Last updated: 2020-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study