摘要
目的评价健康受试者空腹和餐后条件下单剂量服用盐酸西替利嗪片受试制剂和参比制剂是否具有生物等效性。方法采用随机、开放、单剂量、自身交叉设计,液相色谱串联质谱(LC-MS/MS)法测定健康受试者空腹或餐后给药后血浆中西替利嗪的药物浓度,使用Phoenix WinNonlin 8.0软件计算药动学参数,使用SAS 9.4软件进行生物等效性评价。结果空腹BE试验:24名健康受试者分别单次空腹服用受试制剂和参比制剂10 mg后,C max、AUC 0~t、AUC 0~∞几何均数的比值分别为100.18%、96.37%、96.00%,其90%置信区间分别为95.72%~14.84%、92.37%~100.55%、91.77%~100.42%,均落在等效区间80.00%~125.00%之间;餐后BE试验:22名健康受试者分别单次餐后服用受试制剂和参比制剂10 mg后,C max、AUC 0~t、AUC 0~∞几何均数的比值分别为103.98%、102.19%、101.58%,其90%置信区间分别为98.31%~109.97%、98.33%~106.20%、98.07%~105.20%,均落在等效区间80.00%~125.00%之间。结论两种制剂对于空腹和餐后条件下的健康成年受试者具有生物等效性。
Objective To evaluate the bioequivalence of preparations and reference subjects in a single dose of Cetirizine Hydrochloride Tablets under fasting and postprandial conditions in healthy volunteers.Methods A random,open label,single-dose,self-crossover test was designed.LC-MS/MS was applied to determine the concentration of cetirizine in plasma of healthy subjects after fasting or postprandial administration,while Phoenix WinNonlin 8.0 and SAS 9.4 software were used for pharmacokinetics(PK)parameters calculation and bioequivalence analysis,respectively.Results In the fast test,24 healthy subjects took the test preparation and the reference preparation 10 mg on a single fasting.The ratio of the geometric mean of C max,AUC 0~t,AUC 0~∞were 100.18%,96.37%,96.00%,respectively.The 90%confidence intervals of C max,AUC 0~t,AUC 0~∞were 95.72%~14.84%,92.37%~100.55%,91.77%~100.42%,respectively.All these data were falling within the equivalent interval of 80.00%~125.00%.In the postprandial test,22 healthy subjects took the test and reference preparations 10 mg after a single meal.The ratio of the geometric mean of C max,AUC 0~t,AUC 0~∞were 103.98%,102.19%101.58%,respectively,with 90%confidence intervals of 98.31%~109.97%,98.33%~106.20%,98.07%~105.20%,respectively,all of which were falling within the equivalent range of 80.00%~125.00%.Conclusion The two formulations were bioequivalent to healthy adult volunteers under fasting and postprandial conditions.
作者
司鸽
郭建艳
张红贞
高娟
郑忠辉
SI Ge;GUO Jianyan;ZHANG Hongzhen;GAO Juan;ZHENG Zhonghui(Zibo Vocational Institute,Zibo 255314,China;Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255035,China;Department of Basic Teaching,Shandong Drug and Food Vocational College,Zibo 255011,China)
出处
《药学研究》
CAS
2020年第9期520-524,共5页
Journal of Pharmaceutical Research
