文档介绍：富马酸***替芬分散片在健康人体的药动学及生物等效性评价
作者:陈晓莉,文爱东,赵磊,王萌,吴寅,李宏力
【关键词】富马酸***替芬
【Abstract】 AIM: To investigate the ics and bioequivalence of ketotifen fumarate in healthy volunteers. METHODS: A single oral dose of the tested and control ketotifen fumarate was given respectively to 12 healthy volunteers in a randomized twoperiod crossover study. The serum concentration of the two drugs was determined at different time points within 36 hours following the administration by liquid chromatographicmass spectrometric. The main ics parameters were calculated and the bioequivalence was evaluated by two oneside t test and 90% confidence intervals. RESULTS: The main ics parameters were tmax: (±) and (±)h, cmax: (407±147)and(389±168)ng/L, t1/2:(±)and(±)h, and AUC:(2900±1043)and(2763±977)ng/(h・L). The relative bioavailability of the tested drug was (112±39)%. CONCLUSION: Compared with the control, tested ketotifen fumarate has the advantages of faster absorption and higher bioavailability. The results of statistical analysis indicate that the two drugs are bioequivalent in healthy volunteers (P<).
【Keywords】 ketotifen fumarate; chromatography, liquid; spectrum analysis, mass; ics; biological availalility
【摘要】目的: 研究富马酸***替芬分散片在健康人体的药代动力学特征及其生物等效性评价. 方法: 12名健康志愿受试者,采用标准二阶段交叉设计试验方法,分别单剂量po富马酸***替芬分散片(受试品)和富马酸***替芬片(参比品)2 mg,以液相色谱质谱质谱联用法测定服药后36 h内不同时刻的血药浓度,计算主要药动学参数,