NCT06685341

PK/PD Study of YZJ-1139

A Randomized, Double-Blind, Zolpidem and Placebo-Controlled, 4-Way-Period Crossover, Pharmacokinetics and Pharmacodynamics Study of YZJ-1139 Single-Dose Oral in Healthy Young and Elderly Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Insomnia

Interventions

Type	Name	Description
DRUG	YZJ-1139	YZJ-1139
DRUG	Placebo	Oral tablet
DRUG	Zolpidem	Oral tablet

Timeline

• Start date: 2019-03-07
• Primary completion: 2019-04-10
• Completion: 2019-11-15
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China