[Translation] A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of Yanhouning oral solution in healthy Chinese subjects
选择健康志愿者为受试者,从安全的初始剂量开始,通过剂量递增试验,观察人体对咽喉宁口服液的安全性和耐受性;检测健康人服用咽喉宁口服液后,血浆中苦参碱、氧化苦参碱、金雀花碱、N-甲基金雀花碱、龙葵碱、澳洲茄碱、澳洲茄边碱、β-澳洲茄边碱、α-卡茄碱的浓度,研究其在人体的暴露情况,为制定本品的Ⅱ期临床试验给药方案和质量控制提供数据支持。
[Translation] Healthy volunteers were selected as subjects, and starting from a safe initial dose, a dose escalation test was conducted to observe the safety and tolerability of the Yanhou Ning oral liquid in humans. The concentrations of matrine, oxymatrine, cytisine, N-methyl cytisine, solanine, chaconine, chaconine, β-chaconine, and α-chaconine in plasma were tested after healthy people took the Yanhou Ning oral liquid, and their exposure in humans was studied to provide data support for the formulation of the dosing regimen and quality control for the Phase II clinical trial of this product.