生物等效性
医学
药效学
交叉研究
药代动力学
药理学
置信区间
内科学
安慰剂
病理
替代医学
作者
Juan Yan,Xiaomin Li,Yanxin Zhang,San Xu,Wanli Liu,Jie Guo,Xiaolei Hu,Ting Zou,Yuehua Xu,Ping Xu
摘要
Abstract The aim of this study was to explore the bioequivalence of miglitol based on pharmacodynamic properties. The study was performed as a single‐dose, randomized, open‐label, 3‐period, 3‐way crossover trial over a 7‐day washout period. Forty‐eight subjects were randomly assigned into 3 groups: (1) miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone. Serum glucose concentrations were measured by the hexokinase detection method. The peak serum glucose concentration (C max ) and the area under the serum glucose concentration‐time curve through 4 hours (AUC 0‐4h ) were used as the main pharmacodynamic parameters to evaluate bioequivalence. The 90% confidence intervals for the geometric mean ratios of C max and AUC 0‐4h were 94.81%‐101.07% and 98.82%‐100.72%, respectively, which were all within the bioequivalence range of 80.00%‐125.00%. The test and reference formulations of miglitol were pharmacodynamically bioequivalent during the trial.
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