Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867343
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2021-04-24
Brief Title:
Pharmacokinetics Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
Pharmacokinetics Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 verificationThe 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 212 and 1218age groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None