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Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder

NCT06975514 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-15

No results posted yet for this study

Summary

The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Conditions

  • Insomnia Disorder

Interventions

DRUG

YZJ-1139

YZJ-1139 20mg tablets, once daily in the evening

DRUG

Zolpidem

Zolpidem 10mg tablets, once daily in the evening

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • China

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 NCT06975514 on ClinicalTrials.gov