盐酸左西替利嗪片在中国健康志愿者的生物等效性  

Bioeqivalence of Levocetirizine Hydrochloride Tablet in Healthy Chinese Volunteers

作　　者：张军[1,2] 樊玲 葛芹 丁峰[2] 周焕[2] Zhang Jun;Fan Ling;Ge Qin;Ding Feng;Zhou Huan(Blood Transfusion Branch The First Affiliated Hospital of Bengbu Medical College,Bengbu 233000;National Drug Clinical Trial Institution The First Affiliated Hospital of Bengbu Medical College,Bengbu 233000,China)

机构地区：[1]蚌埠医学院第一附属医院输血科,安徽蚌埠233000 [2]蚌埠医学院第一附属医院国家药物临床试验机构,安徽蚌埠233000

出　　处：《广东化工》2020年第8期44-46,35,共4页Guangdong Chemical Industry

基　　金：合肥英太制药有限公司委托研发课题(byyfyll2019008)。

摘　　要：目的:研究盐酸左西替利嗪片受试制剂与参比制剂在空腹及餐后状态下的药代动力学、生物等效性及安全性。方法:采用随机、开放、单剂量、两周期双交叉试验设计,每周期服用一片参比制剂或受试制剂,给药前后静脉采血,HPLC-MS/MS法测定血药浓度,SAS 9.4版本软件计算药代动力学参数。结果:在空腹和餐后状态下,盐酸左西替利嗪片受试制剂或参比制剂的主要药动学参数(Cmax,AUC0-t,AUC0-∞)的几何均数比值90%置信区间均在80.00%~125.00%的范围内,且均未发生死亡等严重不良反应事件。结论:空腹及餐后状态下,盐酸左西替利嗪片受试制剂与参比制剂均具有生物等效性,且安全性良好。Objective:To evaluate the pharmacokinetics,bioequivalence and safety of levocetirizine hydrochloride tablet test products and reference producets in healthy chinese volunteers after single oral administration under fasting and fed conditions.Methods:A single-dose,randomized,open-label,two-period crossover study was designed.Received 5 mg of either test or reference levocetirizine hydrochloride tablet,respectively,and the plasma concentration of the drug was determined by HPLC-MS-MS,using SAS 9.4 calculate the pharmacokinetic parameters.Results:The 90%CIs of the geometric mean raction of Cmax,AUC0-t and AUC0-∞between the test and reference drug fell with in the limit ranges of 80.00%~125.00%under fasting and fed conditions,respectively.No serious adverse events such as death occurred.Conclusion:The exposures were equivalence and safe between two levocetirizine hydrochloride tablets administered with food or fasted in Chinese healthy volunteers.

关 键 词：盐酸左西替利嗪片 生物等效性 药代动力学 安全性 

分 类 号：TQ[化学工程]