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NCT06326723

Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability After Single- and Multiple-Dose Daridorexant in Chinese Healthy Subjects
Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Daridorexant
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Location
Nanjing, China
Timeline & enrollment
Phase
Phase 1
Start date
Sep 04, 2023
End date
Feb 05, 2024
Enrollment
32 participants
Primary outcome

Pharmacokinetic Endpoints1,Pharmacokinetic Endpoints2,Pharmacokinetic Endpoints3,Pharmacokinetic Endpoints4,Pharmacokinetic Endpoints5,Pharmacokinetic Endpoints6,Pharmacokinetic Endpoints7

Summary

This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1
 clinical study to assess the PK characteristics and safety and tolerability of single and
 multiple dose daridorexant in 32 healthy adult Chinese subjects.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06326723
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06326723 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. and is currently Completed. The study focuses on Healthy Volunteer. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.