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

Phase 1
Waitlist Available
Research Sponsored by Yantai YenePharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 hours to 36 hours
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and well tolerated in healthy male and female adults. Researchers will also look at how the body processes the drug.

Eligible Conditions
  • Stroke
  • Intracranial Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 hours to 36 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 hours to 36 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Secondary study objectives
Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t]
Maximum Plasma Concentration [Cmax]
Time of Observed Cmax[tmax]

Side effects data

From 2006 Phase 4 trial • 401 Patients • NCT00200356
30%
Constipation
12%
Insomnia
10%
Nasopharyngitis
6%
Back pain
6%
Headache
5%
Urinary tract infection
5%
Pruritus
5%
Diarrhea
3%
Cerebral infarction
1%
Vertigo
1%
Femur fracture
1%
Lymphoma
1%
Angina pectoris
1%
Pelvic fracture
1%
Ileus
1%
Anti-neutrophil cytoplasmic antibody positive vasculitis
1%
Depression
1%
Transient ischemic attack
1%
Anastomotic ulcer haemorrhage
1%
Asthma
1%
Cerebral haemorrhage
1%
Duodenal ulcer
1%
Arrhythmia
1%
Duodenal ulcer haemorrhage
1%
Femoral neck fracture
1%
Inguinal hernia
1%
Psychotic disorder due to a general medical condition
1%
Pneumonia
1%
Thrombotic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Edaravone
Ozagrel

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Y-2(Edaravone And Borneol) sublingual tabletExperimental Treatment1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yantai YenePharma Co., Ltd.Lead Sponsor
~3 spots leftby Dec 2025
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