Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570655
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-04-27
Brief Title:
The Study of Pharmacokinetics and Pharmacodynamics of Huperzine A Injection in Healthy Chinese Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Study of Pharmacokinetics and Pharmacodynamics of Huperzine A Injection in Healthy Chinese Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study used a single-center open sequential single-dose design To evaluate the pharmacokinetics and dose-exposure relationship of huperzine A injection
Detailed Description:
The study was divided into four modes of administration Administration method of A intravenous injection non-blood collection arm intravenous injection of 02mg huperzine A injection B C D Administration methods 01mg 02mg 04mg huperzine A injection was injected intramuscularly into the deltoid muscle of the upper arm the arm on the non-blood collection side In each cycle after fasting for at least 10 hours the subjects received different dosing regimens according to A sequential single dosing method that is each subject received dosing method A first followed by dosing method B after the cleaning period dosing method C after the cleaning period and dosing method D after the cleaning period The wash-out period between the two doses was 7 days for each subject To evaluate the pharmacokinetics and dose-exposure relationship of huperzine A injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None