盐酸伊托必利片在健康受试者中的生物等效性研究

Study on the Bioequivalence of Itopride Hydrochloride Tablets in Healthy Subjects

关键词:  盐酸伊托必利片  生物等效性  药动学  高效液相色谱-串联质谱法

Key words:  itopride hydrochloride tablets  bioequivalence  pharmacokinetics  HPLC-MS/MS

摘要:

目的 评价盐酸伊托必利片的生物等效性。方法 采用HPLC-MS/MS测定血浆中伊托必利的浓度。64例健康受试者(空腹32例,餐后32例)随机交叉单剂量口服盐酸伊托必利片受试制剂和参比制剂50 mg,测定不同时间血药浓度,采用Phoenix WinNonlin软件对药动学参数进行计算。结果 空腹试验C_max、AUC_0-t、AUC_0-∞几何均数比值的90%置信区间分别为89.42%~118.95%、93.25%~117.27%、92.78%~117.33%;餐后试验90%置信区间分别为90.53%~104.83%、96.72%~99.77%、96.76%~99.88%。结论 盐酸伊托必利片受试制剂和参比制剂具有生物等效性。

Abstract:

OBJECTIVE To evaluate the bioequivalence of itopride hydrochloride tablets.METHODS The concentration of itopride in plasma was measured by HPLC-MS/MS.Sixty-four healthy subjects (32 on fasting and 32 after meal) were randomly assigned to take a single dose of itopride hydrochloride tablets 50 mg orally as test preparation and reference preparation.The plasma concentrations of itopride hydrochloride tablets were determined at different times and the pharmacokinetic parameters were calculated by Phoenix WinNonlin software.RESULTS Under fasting conditions,the 90% confidence intervals of C_max,AUC_0-t and AUC_0-∞ for the test/reference geometric mean ratio were 89.42%-118.95%,93.25%-117.27%,92.78%-117.33%.Under fed conditions,the 90% confidence intervals of C_max,AUC_0-t and AUC_0-∞ for the test/reference geometric mean ratio were 90.53%-104.83%,96.72%-99.77%,96.76%-99.88%.CONCLUSION The test preparation and reference preparation of itopride hydrochloride tablets are bioequivalent.