[Translation] Phase I clinical trial evaluating salvianolic acid A sodium for injection in Chinese healthy subjects in a randomized, double-blind, placebo-controlled, single- and multiple-dose
1、评价注射用丹酚酸A钠在健康受试者中单次给药的耐受性、安全性及药代动力学特征,并考察两种溶媒的影响; 2、评价注射用丹酚酸A钠在健康受试者中多次给药的耐受性、安全性和药代动力学特征,并初步评价药效学; 3、考察注射用丹酚酸A钠皮试阳性发生率。
[Translation] 1. To evaluate the tolerability, safety and pharmacokinetic characteristics of a single dose of salvianolic acid A sodium for injection in healthy subjects, and to investigate the effects of two solvents; 2. To evaluate salvianolic acid for injection Tolerance, safety and pharmacokinetics of sodium A in healthy subjects after repeated administration, and preliminary evaluation of pharmacodynamics; 3. To investigate the incidence of positive skin test of salvianolic acid A sodium for injection.