[Translation] A randomized, double-blind, placebo-controlled phase I clinical study on the safety, tolerability and pharmacokinetic characteristics of strychnine alkaloids vesicle gel after single and repeated administration in Chinese healthy subjects
(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) Conduct human tolerance test of strychnine alkaloids vesicle gel on healthy adult subjects to determine the human tolerance dose range and safety;
(2) Conduct pharmacokinetic test at the same time as tolerance test to detect the blood concentration of strychnine and strychnine, components of strychnine vesicle gel, estimate pharmacokinetic parameters, and evaluate its pharmacokinetic characteristics;
(3) Provide experimental basis for the formulation of late clinical trial plan of strychnine vesicle gel.