经口吸入制剂在中国健康受试者生物等效性试验中的安全性分析  

Safety analysis on bioequivalence studies of orally inhaled drug products in healthy Chinese subjects

作　　者：刘敏 孔祥 章叶 顾逸飞 项雪梅 黄凯 LIU Min;KONG Xiang;ZHANG Ye;GU Yifei;XIANG Xuemei;HUANG Kai(Drug Clinical Trial Institution,Affiliated Wuxi People's Hospital of Nanjing Medical University,Wuxi 214023,Jiangsu,China;Department of Endocrinology,The First Aflliated Hospital of Wannan Medical College,Yijishan Hospital,Wuhu 241001,Anhui,China;Wuxi Clinical Medical School of Nanjing Medical University,Wuxi 214023,Jiangsu,China)

机构地区：[1]南京医科大学附属无锡人民医院药物临床试验机构,江苏无锡214023 [2]皖南医学院第一附属医院弋矶山医院内分泌科,安徽芜湖241001 [3]南京医科大学无锡临床医学院,江苏无锡214023

出　　处：《中国临床药理学与治疗学》2023年第10期1131-1138,共8页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金项目(81600645)。

摘　　要：目的:探讨无锡市人民医院Ⅰ期临床研究中心开展的经口吸入制剂(OIDPs)生物等效性试验的安全性。方法:收集2017-2022年在无锡人民医院参加20项OIDPs生物等效性试验的482例健康受试者的安全性数据,比较受试制剂和参比制剂发生不良事件(AE)的差异性,以及性别、年龄、作用机制、装置类型对AE的影响。结果:77例受试者(16.0%,77/482)共发生AE 102例次,与试验药物相关AE 87例次,均属于轻、中度,无严重不良事件发生。受试制剂和参比制剂的药物相关AE发生率并无差异,性别、年龄、药物作用机制和装置类型对AE发生也无明显影响。结论:在20项OIDPs生物等效性试验中,健康受试者用药后安全性、耐受性良好,且OIDPs仿制药和原研药的安全性特征基本相似。AIM:To investigate the safety of bioequivalence(BE)studies of orally inhaled drug products(OIDPs)conducted by Phase I clinical Research Center of our hospital.METHODS:The safety data were collected from 482 healthy subjects enrolled in 20 OIDPs BE studies in Wuxi People's hospital from 2017 to 2022.The difference of adverse events(AEs)between test preparation and reference preparation were compared,as well as the influence of gender,age,mechanism of drug action and device type on AE were analyzed.RESULTS:A total of 102 cases of AEs were occurred in 77 subjects(16.0%,77/482),87 cases of AEs were related to experimental drugs,all AEs were mild or moderate,and no serious adverse events occurred.There was no difference in the incidence of AE between test preparation and reference preparation.In addition,gender,age,mechanism of drug action and device type had no significant effects on AEs.CONCLUSION:In 20 bioequivalence studies of OIDPs,OIDPs were safe and well tolerated in healthy subjects after dosing,and safety features of generic OIDPs and original drug were basically similar.

关 键 词：经口吸入制剂 健康受试者 生物等效性试验 安全性分析 

分 类 号：R969[医药卫生—药理学]