[Translation] The human bioequivalence study of epalrestat tablets was conducted using a single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design, with administration on an empty stomach.
本试验旨在研究单次空腹口服焦作市明仁天然药物有限责任公司研制、生产的依帕司他片(50 mg)的药代动力学特征;以Alfresa Pharma Corporation生产的依帕司他片(KINEDAK®,50 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of a single fasting oral dose of epalrestat tablets (50 mg) developed and produced by Jiaozuo Mingren Natural Medicine Co., Ltd.; using epalrestat tablets (KINEDAK®, 50 mg) produced by Alfresa Pharma Corporation as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.