摘要
目的:评估受试制剂马来酸伊索拉定片(某制药有限公司生产)和参比制剂马来酸伊索拉定片(Gaslon N■)作用于空腹和餐后状态下健康成年受试者的生物等效性及安全性。方法:采用随机、开放、单剂量、两周期、两序列、两交叉设计,于每周期给药前后静脉采血,采用LC/MS/MS法测定血药浓度,采用SAS V9.3软件进行药代动力学分析。结果:在空腹和餐后状态下,马来酸伊索拉定片受试制剂及参比制剂的Cmax,AUC0-t,AUC0-∞的几何均数比值90%置信区间均在80.00%~125.00%的范围内,且未发生严重不良事件。结论:受试制剂马来酸伊索拉定片(某制药有限公司生产)和参比制剂马来酸伊索拉定片(Gaslon N■)在空腹和餐后状态下均具有生物等效性,且安全性良好。
Objective:To evaluate the pharmacokinetics,bioequivalence and safety of Isoradine maleate tablet test products(produced by a pharmaceutical co.LTD)and reference producets(Gaslon N■)in healthy adult subjects after single oral administration under fasting and fed conditions.Methods:A single-dose,randomized,open-label,two-period crossover study was designed.Blood was collected before and after administration and the plasma concentration of the drug was determined by LC/MS/MS,using SAS 9.3 calculate the pharmacokinetic parameters.Results:The 90%CIs of the geometric mean raction of Cmax,AUC0-t and AUC0-∞between the test and reference drug fell with in the limit ranges of 80.00%~125.00%under fasting and fed conditions,respectively.No serious adverse events occurred.Conclusion:The exposures were equivalence and safe between two Isoradine maleate tablet administered under fasting and fed conditions in Chinese healthy adult subjects.
作者
周焕
樊玲
尚喆
朱行宇
丁峰
Zhou Huan;Fan Ling;Shang Zhe;Zhu Xingyu;Ding Feng(National Drug Clinical Trial Institution The First Affiliated Hospital of Bengbu Medical College,Bengbu 233000;College of pharmacy Bengbu Medical College,Bengbu 233000,China)
出处
《广东化工》
CAS
2020年第11期74-76,78,共4页
Guangdong Chemical Industry
基金
齐鲁制药有限公司委托研发课题(伦理号2018097)
药物临床试验登记与信息公示平台登记号:CTR20190535。
关键词
马来酸伊索拉定片
生物等效性
安全性
Isoradine maleate tablet
bioequivalence
safety evaluation
