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PK/PD Study of YZJ-1139

NCT06685341 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-12

No results posted yet for this study

Summary

Primary Objective： To determine the dose-response relationship of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.

Secondary Objective: To investigate the safety and tolerability of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.

Conditions

Interventions

DRUG

YZJ-1139

YZJ-1139

DRUG

Placebo

Oral tablet

DRUG

Zolpidem

Oral tablet

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2019-04-10
Completion
2019-11-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06685341 on ClinicalTrials.gov