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Y-2 Sublingual Tablet for Healthy Subjects

Phase 1
Waitlist Available
Led By David Han, MD
Research Sponsored by Simcere Pharmaceutical 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 day1，day2， day6，day7，day11，day12
Awards & highlights

Study Summary

This trial tests a new tablet to see if it is safe, tolerable and effective for adults with no medical conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1，day2， day6，day7，day11，day12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1，day2， day6，day7，day11，day12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events（Part 1)
Area under the curve (AUC) in Part 2 healthy adult subjects
Maximum concentration（Cmax）in Part 2 healthy adult subjects
+2 more
Secondary outcome measures
Adverse Events（Part 2)
Area under the curve (AUC) in Part 1 healthy adult subjects
Maximum concentration（Cmax）in Part 1 healthy adult subjects
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Y-2 sublingual tablet dose group 1Experimental Treatment1 Intervention
Group II: Y-2 sublingual tablet dose Group 5Experimental Treatment1 Intervention
Group III: Y-2 sublingual tablet dose Group 4Experimental Treatment1 Intervention
Group IV: Y-2 sublingual tablet dose Group 3Experimental Treatment1 Intervention
Group V: Y-2 sublingual tablet dose Group 2Experimental Treatment1 Intervention
Group VI: PlaceboPlacebo Group1 Intervention
Certain subjects in group 1 and group 2 will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Y-2 Sublingual Tablet
2023
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Simcere Pharmaceutical Co., LtdLead Sponsor
17 Previous Clinical Trials
3,569 Total Patients Enrolled
David Han, MDPrincipal InvestigatorParexel
10 Previous Clinical Trials
416 Total Patients Enrolled

Media Library

Y-2 Sublingual Tablet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05940883 — Phase 1
Healthy Subjects Research Study Groups: Y-2 sublingual tablet dose group 1, Y-2 sublingual tablet dose Group 2, Y-2 sublingual tablet dose Group 3, Y-2 sublingual tablet dose Group 4, Y-2 sublingual tablet dose Group 5, Placebo
Healthy Subjects Clinical Trial 2023: Y-2 Sublingual Tablet Highlights & Side Effects. Trial Name: NCT05940883 — Phase 1
Y-2 Sublingual Tablet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05940883 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals eligible for participation in this experiment?

"This medical research is recruiting individuals who have attained the age of majority and are below 55 years old."

Answered by AI

Has the Y-2 sublingual tablet dose group 1 been given regulatory approval?

"Due to the preliminary nature of this Phase 1 trial, which only has limited data supporting safety and efficacy, our team at Power assigns a score of 1 for Y-2 sublingual tablet dose group 1's relative safety."

Answered by AI

Who are the eligible participants for this research endeavor?

"To qualify for this research, applicants must be in good health and between 18-55 years old. The desired number of participants is 36 individuals."

Answered by AI

Are there any vacancies in the clinical trial currently?

"The clinicaltrials.gov listing shows that the study, which was initially published on July 1st 2023 has ceased to accept applicants. Although this is no longer actively recruiting, 796 other trials are presently open for enrolment."

Answered by AI

What purpose is this experiment trying to fulfill?

"This research study, which is expected to conclude on or before Day 26 follow-up, aims to measure Maximum Concentration (Cmax) in Part 2 healthy adult subjects. Secondary goals include determining Time for Cmax (Tmax), Area under the Curve (AUC), and Terminal Elimination Half-Life (1/2) of edaravone and dexborneol following single and multiple administrations of Y-2 sublingual tablet amongst healthy adults in Part 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects
2023. "A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05940883.
~23 spots leftby Apr 2025
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