双嘧达莫片在健康人体生物等效性研究  

Bioequivalence of dipyridamole tablets in healthy volunteers

作　　者：胡义亭[1] 宋浩静[1] 许玉芳[1] 毕璐莎 赵娜[1] 贾彩云[1] 白万军[1] 邱博[1] 史犇 董占军[1] HU Yi-ting;SONG Hao-jing;XU Yu-fang;BI Lu-sha;ZHAO Na;JIA Cai-yun;BAI Wan-jun;QIU Bo;SHI Ben;DONG Zhan-jun(PhaseⅠClinical Laboratory,Hebei General Hospital,Shijiazhuang 050051,Hebei Province,China;CSPC Zhongqi Pharmaceutical Co.,Ltd.,Shijiazhuang 050035,Hebei Province,China;Suzhou Guochen Biotechnology Co.,Ltd,Suzhou 215000,Jiangsu Province,China)

机构地区：[1]河北省人民医院Ⅰ期临床研究室,河北石家庄050051 [2]石药集团中奇制药技术(石家庄)有限公司,河北石家庄050035 [3]苏州国辰生物科技股份有限公司,江苏苏州215000

出　　处：《中国临床药理学杂志》2022年第14期1683-1687,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究健康受试者空腹和餐后条件下单剂量口服双嘧达莫片受试制剂和参比制剂的生物等效性。方法用单剂量、随机、开放、自身交叉设计,用液相色谱串联质谱(LC-MS/MS)法测定给药后血浆中双嘧达莫的药物浓度,用Phoenix WinNonlin 8.0软件进行药代动力学参数计算,用SAS 9.4软件进行生物等效性评价。结果空腹生物等效性试验:37例健康受试者空腹单次口服双嘧达莫受试制剂和参比制剂25 mg后,C_(max)、AUC_(0-t)及AUC_(0-∞)的几何均值的比值分别为107.44%,101.76%和101.91%,90%置信区间(CI)分别为98.11%~117.67%,94.59%~109.47%,94.99%~109.34%,均值均落在等效置信区间80.00%~125.00%;餐后生物有效性试验:38例健康受试者高脂餐后单次口服受试制剂和参比制剂25 mg后,C_(max)、AUC_(0-t)及AUC_(0-∞)的几何均值的比值分别为101.19%,102.41%和102.02%,90%CI分别为88.67%~115.48%,93.29%~112.42%和93.11%~111.77%,均落在等效置信区间80.00%~125.00%。结论健康成年受试者在空腹和餐后条件下,单次口服受试制剂和参比制剂具有生物等效性。Objective To evaluate the bioequivalence of test product(T)and reference product(R)in a single dose of dipyridamole tablet under fasting and fed conditions in healthy volunteers.Methods An open label,randomized,balanced,single dose,crossover bioequivalence study was designed.LC-MS/MS was applied to determine the concentration of dipyridamole in plasma of healthy subjects after fasting or fed administration,while Phoenix WinNonlin 8.0 and SAS 9.4 software were used for pharmacokinetics(PK)parameters calculation and bioequivalence analysis,respectively.Results A total of 37 healthy subjects took the test product(T)and the reference product(R)25 mg under fasting condition.The geometric mean ratio(T/R)of C_(max),AUC_(0-t) and AUC_(0-∞) were 107.44%,101.76%,101.91%respectively.The 90%confidence intervals of C_(max),AUC_(0-t) and AUC_(0-∞) were 98.11%-117.67%,94.59%-109.47%and 94.99%-109.34%respectively.All these data were falling within the equivalent interval of 80.00%-125.00%.A total of 38 healthy subjects took the test and reference preparations 25 mg under fed condition.The geometric mean ratio(T/R)of C_(max),AUC_(0-t) and AUC_(0-∞) were 101.19%,102.41%and 102.02%respectively,with 90%confidence intervals of 88.67%-115.48%,93.29%-112.42%and 93.11%-111.77%,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 fed conditions.

关 键 词：双嘧达莫 生物等效性 药代动力学 

分 类 号：R97[医药卫生—药品]