[Translation] A randomized, double-blind, placebo-controlled, single/continuous administration phase I clinical trial of the safety, tolerability and pharmacokinetics of Shendantongnao dripping pills in healthy subjects;
选择健康志愿者为受试者,从安全初始计量开始,通过计量递增试验,观察人体对参丹通脑滴丸的安全性和耐受性;检查健康人使用参丹通脑滴丸后,血中阿魏酸、丹酚酸B、丹酚酸IIA、人参皂甙Rb1、人参皂苷Rg1和人参皂苷Re的浓度,并研究其人体药代动力学特征,为制定本品II期临床试验方案和质量控制提供数据支持;
[Translation] Healthy volunteers were selected as subjects, and starting from the initial safe dose, a dose-increase test was conducted to observe the safety and tolerance of Shendantongnao dripping pills in the human body; the concentrations of ferulic acid, salvianolic acid B, salvianolic acid IIA, ginsenoside Rb1, ginsenoside Rg1 and ginsenoside Re in the blood of healthy people after using Shendantongnao dripping pills were examined, and their human pharmacokinetic characteristics were studied to provide data support for the formulation of the Phase II clinical trial plan and quality control of this product;