伊布替尼胶囊在健康受试者中的生物等效性研究  

Bioequivalence study of Ibrutinib Capsules in healthy volunteers

作　　者：徐桥 李亚娟 陈路路 李剑[2] 张嫣红 XU Qiao;LI Yajuan;CHEN Lulu;LI Jian;ZHANG Yanhong(Jiangxi Kerui Pharmaceutical Industry Co.,Ltd.,Ganzhou 341000,China;The Second Affiliated Hospital of Nanchang University,Nanchang 330000,China;Suzhou Biyi Biotechnology Co.,Ltd.,Suzhou 215000,China)

机构地区：[1]江西科睿药业有限公司,江西赣州341000 [2]南昌大学第二附属医院,江西南昌330000 [3]苏州必宜生物科技有限公司,江苏苏州215000

出　　处：《现代药物与临床》2024年第11期2815-2822,共8页Drugs & Clinic

摘　　要：目的评价伊布替尼胶囊受试制剂、参比制剂在空腹、餐后条件下的生物等效性。方法本研究为空腹和餐后条件下、单中心、随机、开放、两制剂、两序列、四周期、完全重复交叉试验设计生物等效性试验。空腹和餐后分别入组40、32例健康受试者,每周期口服140 mg伊布替尼胶囊受试制剂、参比制剂。采用LC-MS/MS法分析伊布替尼的血药浓度,药动学参数计算由Phoenix WinNonlin 8.3版本软件完成,其他统计分析使用SAS 9.4版本软件完成。结果健康受试者空腹、餐后状态下药动学参数C_(max)、AUC_(0-t)、AUC_(0-∞)经对数转换后点估计值均完全落入[80.00%,125.00%]。结论健康受试者空腹、餐后状态下口服伊布替尼胶囊受试制剂和参比制剂具有生物等效性。Objective To evaluate the bioequivalence of test and reference preparation of Ibrutinib Capsules under fasting and fed condition.Methods A single center,randomized,open label,two-formulation,two-sequence,four-period and completely repeated crossover trial under fasting and fed condition.40 Cases and 32 healthy subjects were enrolled under fasting and fed condition,respectively,and 140 mg test and reference preparation of Ibrutinib Capsules were taken orally every cycle.The plasma concentration of ibrutinib was analyzed by LC-MS/MS method.Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.3,and other statistical analysis was performed by SAS 9.4.Results The pharmacokinetic parameters C_(max),AUC_(0-t),and AUC_(0-∞)of healthy subjects under fasting and fed condition all fell within the range of[80.00%,125.00%]after logarithmic transformation.Conclusion The test or reference product of Ibrutinib Capsules is bioequivalent in healthy volunteers under fasting and fed condition after a single oral administration.

关 键 词：伊布替尼胶囊 伊布替尼 药动学 LC-MS/MS法 生物等效 

分 类 号：R969.1[医药卫生—药理学]