NCT04867343

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	HR020602 injection	HR020602 injection
DRUG	fentanyl injection ； remifentanil injection	fentanyl injection + remifentanil injection

Timeline

• Start date: 2021-06-07
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2021-04-30
• Last updated: 2024-03-04

Locations

1 site across 1 country: China