[Translation] Randomized, double-blind, placebo-controlled phase I of safety, tolerability, and pharmacokinetics of strychnine total alkaloids vesicle gel following single and multiple administrations in healthy Chinese subjects clinical research
(1)以健康成年受试者为研究对象,进行马钱子总碱囊泡凝胶人体耐受性试验,确定人用耐受剂量范围和安全性;
(2)在耐受性试验的同时开展药代动力学试验,检测马钱子总碱囊泡凝胶成分马钱子碱和士的宁的血药浓度,并估算药动学参数,评价其药动学特征;
(3)为马钱子总碱囊泡凝胶后期临床试验方案制定提供试验依据。
[Translation] (1) Taking healthy adult subjects as the research objects, the human tolerance test of total alkaloid vesicle gel of strychnine strychnine was conducted to determine the tolerance range and safety of human doses;
(2) Pharmacokinetic tests were carried out at the same time as the tolerance test to detect the plasma concentrations of strychnine and strychnine, the components of total strychnine vesicle gel, and to estimate the pharmacokinetic parameters to evaluate their pharmacokinetic characteristics;
(3) To provide experimental basis for the formulation of the late clinical trial plan of strychnine total alkaloid vesicle gel.