摘要
目的研究国产头孢克肟颗粒与参比制剂在中国健康人体内空腹和餐后状态下的生物等效性。方法采用随机、开放、单次给药,两制剂、两周期、自身交叉的平均生物等效性研究设计,空腹试验和餐后试验分别入组24例成年健康受试者。受试者按随机表分为2组,每周期分别口服受试制剂或参比制剂50 mg。用液相色谱-串联质谱(LC-MS/MS)法检测血浆中头孢克肟的浓度。结果空腹试验,受试制剂与参比制剂的C_(max)、AUC_(0-t)和AUC_(0-∞)几何均值比(90%置信区间,90%CI)分别为103.25%(98.47%~108.26%)、102.75%(98.18%~107.53%)和102.91%(98.33%~107.71%),完全落在80.00%~125.00%。餐后试验,受试制剂与参比制剂的C_(max)、AUC_(0-t)和AUC_(0-∞)的几何均值比(90%CI)分别为98.19%(91.57%~105.28%)、98.94%(92.87%~105.40%)和98.69%(92.77%~104.98%),完全落在80.00%~125.00%。结论在空腹及餐后状态下,中国健康成年受试者单次口服国产头孢克肟颗粒与参比制剂具有生物等效性。
Objective To evaluate the bioequivalence of generic cefixime granules(test)and original cefixime(reference)in Chinese healthy adult subjects under fast and fed conditions.Methods A randomized,open-label,single-dose,two-period crossover design was used.Healthy adults received a single dose of test or reference formulation of cefixime 50 mg at one single period under fasting(n=24 cases)or fed(n=24 cases)conditions.Plasma concentrations of cefixime were analyzed by LC-MS/MS method.Results Under fasting condition,the 90%confidence intervals(CI)for the geometric test/reference mean ratio of the C_(max),AUC_(0-t) and AUC_(0-∞) were 103.25%(98.47%-108.26%),102.75%(98.18%-107.53%)and 102.91%(98.33%-107.71%),respectively.Under fed condition,the 90%CI for the geometric test/reference mean ratio of the C_(max),AUC_(0-t) and AUC_(0-∞) were 98.19%(91.57%-105.28%),98.94%(92.87%-105.40%)and 98.69%(92.77%-104.98%),respectively.They were both completely contained within the established bioequivalence limits of 80.00%to 125.00%.Conclusion Under both fasting and fed conditions,generic cefixime granules and original cefixime were bioequivalent in Chinese healthy adults.
作者
王干迷
王健松
赵桂荣
胡海容
宋文杰
秦飞
WANG Gan-mi;WANG Jian-song;ZHAO Gui-rong;HU Hai-rong;SONG Wen-jie;QIN Fei(Baiyunshan Pharmaceutical General Factory,Guangzhou Baiyunshan Pharmaceutical Hoding Co.Ltd,Guangzhou 510515,Guangdong Province,China;Key Laboratory of Key Technology Research on Chemical Raw Materials and Preparations of Guangdong Province,Guangzhou 510515,Guangdong Province,China;Fangshan Hospital,Beijing University of Chinese Medicine,Beijing 102400,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2021年第21期2941-2945,共5页
The Chinese Journal of Clinical Pharmacology
基金
广东省科技计划基金资助项目(2017B020234005)。
