■为了评估Gan和Lee(GL)甘精U300与Toujeo®之间的药代动力学(PK)生物等效性,药效学(PD),中国健康男性参与者的安全性。
■单中心,随机化,双盲,单剂量,两个准备,两个序列,在40名健康参与者中进行了四周期重复交叉设计研究,以比较GL甘精U300和Toujeo®。主要PK终点是甘精代谢产物的曲线下面积,M1浓度从0到24小时(AUC0-24h),和给药后24小时内的最大甘精胰岛素浓度(Cmax)。主要PD终点是0至24小时的葡萄糖输注速率(GIR)曲线下面积(AUCGIR.0-24h)和给药后24小时内的最大GIR(GIRmax)。
■GL甘精蛋白U300表现出可比的PK参数(AUC0-24h,Cmax,AUC0-12h,和M1的AUC12-24h)和PD响应[AUCGIR.0-24h,GIRmax,AUCGIR.0-12h,和AUCGIR.12-24h]到Toujeo®的那些,如90%置信区间从80%到125%所示。两个治疗组之间在安全性方面没有观察到显著差异,没有严重不良事件的报告.
■PK,PD,GL甘精U300的安全性与Toujeo®生物等效。
■https://www.chinadrugtrials.org.cn/,标识符CTR20212419。
UNASSIGNED: To assess the
bioequivalence between Gan & Lee (GL) glargine U300 and Toujeo® regarding pharmacokinetics (PK), pharmacodynamics (PD), and safety in Chinese healthy male participants.
UNASSIGNED: A single-center, randomized, double-blind, single-dose, two-preparation, two-sequence, four-cycle repeated crossover design study was performed to compare GL glargine U300 and Toujeo® in 40 healthy participants. The primary PK endpoints were the area under the curve of glargine metabolites, M1 concentration from 0 to 24 hours (AUC0-24h), and the maximum glargine concentration within 24 hours post-dose (Cmax). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUCGIR.0-24h) and the maximum GIR within 24 hours post-dose (GIRmax).
UNASSIGNED: GL Glargine U300 demonstrated comparable PK parameters (AUC0-24h, Cmax, AUC0-12h, and AUC12-24h of M1) and PD responses [AUCGIR.0-24h, GIRmax, AUCGIR.0-12h, and AUCGIR.12-24h] to those of Toujeo®, as indicated by 90% confidence intervals ranging from 80% to 125%. No significant disparities in safety profiles were observed between the two treatment groups, and there were no reported instances of serious adverse events.
UNASSIGNED: The PK, PD, and safety of GL glargine U300 were bioequivalent to that of Toujeo®.
UNASSIGNED: https://www.chinadrugtrials.org.cn/, identifier CTR20212419.