NCT06570655

The Study of Pharmacokinetics and Pharmacodynamics of Huperzine a Injection in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Wanbangde Pharmaceutical Group Co., LTD · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 0.2mg huperzine A injection. B, C, D Administration methods: 0.1mg, 0.2mg, 0.4mg 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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Huperzine A injection	intramuscular
DRUG	Huperzine A injection	intravenous bolus

Timeline

• Start date: 2024-05-16
• Primary completion: 2024-06-20
• Completion: 2024-08-29
• First posted: 2024-08-26
• Last updated: 2024-12-19

Locations

1 site across 1 country: China