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Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects - Trial NCT06326723

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.

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NCT06326723
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06326723
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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

Study Focus

Healthy Volunteer

Daridorexant

Interventional

drug

Sponsor & Location

Jiangsu Simcere Pharmaceutical Co., Ltd.

Nanjing, China

Timeline & Enrollment

Phase 1

Sep 04, 2023

Feb 05, 2024

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 person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06326723

Non-Device Trial