The Study of Pharmacokinetics and Pharmacodynamics of Huperzine A Injection in Healthy Chinese Subjects
NCT Number: NCT06570655
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Subjects
Interventions: DRUG: Huperzine A injection|DRUG: Huperzine A injection
Sponsor: Wanbangde Pharmaceutical Group Co., LTD
Collaborators: Zhejiang Hospital
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-16
Completion Date: 2024-08-31
Locations: Clinical trial institution of the Zhejiang Xiaoshan hospital, Hangzhou, China/Zhejiang, 310000, China

Summary:
The study used a single-center, open, sequential single-dose design. To evaluate the pharmacokinetics and dose-exposure relationship of huperzine A injection

Primary Outcome Measures: Pharmacokinetics (PK): Maximum blood concentration of Huperzine A(Cmax), To measure the Cmax of Huperzine A in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK: Area under the Huperzine A blood concentration-time curve from 0min to the time of last concentration(AUC0-t), To measure the AUC0-t of Huperzine A in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK：Area under the Huperzine A blood concentration-time curve from 0min to the infinity time (AUC0-∞), To measure the AUC0-∞ of Huperzine A in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22
Secondary Outcome Measures: PD: maximum efficacy(Emax), Emax is defined as the maximum activities of red blood cell acetylcholinesterase and calculated as the maximum difference between erythrocyte acetylcholinesterase and baseline value. It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PD: Area under the efficacy curve(AUEC), AUEC is defined as the area under the activity-time curve from 0min to the time of last sample collection, which is adjusted for baseline. It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PD: Time to reach maximum efficacy(Tmax), Tmax(PD) is defined as the time to peak activity of red blood cell acetylcholinesterase. It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK: Time to peak maximum concentration of the Huperzine A(Tmax), Tmax(PK) is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK: half life of Huperzine A(t1/2), t1/2 is defined as the time to eliminate half blood concentration of Huperzine A and is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK: λz, λz is defined as the blood concentration elimination rate constant of terminal phase. It is obtained by semilog linear regression with at least 3 non-zero concentration points of the end elimination phase, and the result is the inverse of the slope. It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK: Area under the curve(AUC_%Extrap), AUC_%Extrap is defined as the percentage of residual area which refers to the area under the Huerperzine A blood concentration-time curve. It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK: Clearance(CL), CL is defined as how many milliliters of Huperzine A in blood are eliminated per unit time, it is calculated by the fomula: CL=D/AUC0-∞ (D refers to the dosage of Huperzine A). It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK：Apparent volume of distribution(Vd), Vd is defined as the ratio of the amount of drug in the body to the concentration in the blood after the drug has reached homeostasis in the body. It is calculated by the fomula: Vd=CL/λz. It is measured in 4 different periods of sequential administration in 12 healthy subjects., Day1、Day8、Day15、Day22|PK：Bioavailability(F), F is defined as the ratio of the AUC0-∞ of intramuscular administration and AUC0-∞ of intravenous administration, Day1、Day8、Day15、Day22|Urine excretion of Huperzine A.(UE), UE is defined as the amout of the Huperzine A excreted in urine during the specific time. It is calculated by the fomula: UE=Cut×Vut(Cut refers to concentration of Huperzine A excreted in urine, Vut refers to the volume of urine)., Baseline、Day15-Day17|Cumulative urinary excretion of Huperzine A(CUE), CUE is defined as the total Huperzine A amout excreted in urine during the whole study., Baseline、Day15-Day17|Urine excretion rate(UER), URE is defined as the ratio of the Huperzine A dose excreted in the urine to the dose administered during the specific time period. It is calculated by the fomula: URE=UE/D×100%(D refers to the Huperzine A administration dose), Baseline、Day15-Day17|Cumulative urinary excretion rate(CUER), CURE is defined as the summary of ratio of the Huperzine A dose excreted in the urine to the dose administered during the specific time period. It is calculated by the fomula: CURE=CUE/D×100%(D refers to Huperzine A administration dose)., Baseline、Day15-Day17|Faeces excretion(FE), FE is defined as the amout of the Huperzine A excreted in faeces during the whole study. It is calculated by the fomula: FE=Cf×Vf(Cf refers to concentration of Huperzine A in faeces, Vf refers to the volume of faeces)., Baseline、Day15-Day17|Faeces excretion rate(FER), FER is defined as the ratio of the Huperzine A doses excreted in the faeces to the dose administered.It is calculated by the fomula: FER=FE/D×100%(D refers to Huperzine A administration dose)., Baseline、Day15-Day17|Metabolites of Huperzine A, To analyze the metabolites of Huperzine A by the plasma sample during the period of C and D methods administration and urine and faeces sample during the period of C method administration.(The methods of administration is explained in the detailed description), Day15、Day22|Number of participants with adverse events (AEs) or serious adverse events (SAEs) as assessed by NCI-CTCAE v5.0., Day1-Day28