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

NCT03495206 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-17

No results posted yet for this study

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.

Conditions

  • Stroke, Acute
  • Intracranial Hemorrhages

Interventions

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

Sponsors & Collaborators

  • Yantai YenePharma Co., Ltd.

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2020-12-31
Completion
2021-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495206 on ClinicalTrials.gov