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Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia

NCT04867343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-04

No results posted yet for this study

Summary

This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of \[2,12\] and \[12,18）age groups.

Conditions

  • Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)

Interventions

DRUG

HR020602 injection

HR020602 injection

DRUG

fentanyl injection ； remifentanil injection

fentanyl injection + remifentanil injection

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2023-08-15
Completion
2023-08-15

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 NCT04867343 on ClinicalTrials.gov