雷贝拉唑钠肠溶片在健康受试者中的生物等效性研究
Bioequivalence of rabeprazole sodium enteric-coated tablets in healthy subjects
田杰 1姜雅琦 1张婷 1李梦瑶 1饶夏莉 2甘方良2
作者信息
- 1. 湖北科技学院附属第一医院/咸宁市中心医院临床药理机构办公室,湖北咸宁 437100;湖北科技学院医学部药学院,湖北咸宁 437100
- 2. 湖北科技学院附属第一医院/咸宁市中心医院临床药理机构办公室,湖北咸宁 437100
- 折叠
摘要
目的:研究健康受试者在空腹和餐后条件下单剂量口服雷贝拉唑钠肠溶片受试制剂和参比制剂的生物等效性.方法:空腹与餐后试验各入组26例健康受试者,分别空腹和餐后口服10mg受试制剂或参比制剂.采用超高效液相色谱-串联质谱(UPLC-MS/MS)法检测人血浆中雷贝拉唑的浓度,使用Phoenix WinNonlin 8.2统计软件的非房室模型法(NCA模块)计算雷贝拉唑的药动学参数,并进行生物等效性评价.结果:空腹试验受试制剂和参比制剂雷贝拉唑的Cmax、AUC0-t和AUC0-∞的几何均值比的90％CI分别为85.32％～124.01％、93.76％～111.61％和93.89％～110.21％;餐后试验受试制剂和参比制剂的 Cmax、AUC0-t和 AUC0-∞的几何均值比的 90％CI 分别为 86.73％～114.09％、92.33％～110.62％和 98.74％～110.57％.空腹和餐后条件下受试制剂与参比制剂主要药动学参数的几何均值比的90％CI均在80％～125％范围内.结论:在空腹和餐后条件下单剂量口服雷贝拉唑钠肠溶片受试制剂和参比制剂具有生物等效性.
Abstract
OBJECTIVE To explore the bioequivalence of rabeprazole sodium enteric-coated and reference tablets in healthy subjects under fasting and postprandial conditions.METHODS For 26 healthy volunteers for fasting and postprandial tests,10 mg of test preparation or reference preparation was taken orally respectively.The concentration of rabeprazole in human plasma was determined by UPLC-MS/MS.The pharmacokinetic(PK)parameters of rabeprazole were calculated by non-atrioventricular model(NCA module)of Phoenix WinNonlin 8.2 statistical software.Bioequivalence was evaluated.RESULTS The values of 90％CI of Cmax,AUC0-t and AUC0-∞ geometric mean ratio of fasting test preparation and reference preparation rabeprazole were 85.32％-124.01％,93.76％-111.61％and 93.89％-110.21％.And 90％CI of Cmax,AUC0-t and AUC0-∞ geometric mean ratio of test and reference preparations in postprandial test were 86.73％-114.09％,92.33％-110.62％and 98.74％-110.57％.Under fasting and postprandial conditions,90％CI of geometric mean ratio of PK parameters between test preparations and reference preparations were in the range of 80％-125％.CONCLUSION Test and reference preparations of rabeprazole sodium enteric-coated tablets are bioequivalent under fasting and postprandial conditions.
关键词
雷贝拉唑钠/生物等效性/药动学/肠溶片Key words
rabeprazole/bioequivalence/pharmacokinetics/enteric-coated tablets引用本文复制引用
基金项目
咸宁市科技计划社发类研发重点专项(2021SFYF005)
出版年
2024
NETL
NSTL
万方数据