[Translation] A randomized, open-label, single-dose, fasting, two-formulation, two-sequence, two-period crossover bioequivalence study of epalrestat tablets in healthy adult Chinese subjects
主要目的:以华润紫竹药业有限公司提供的依帕司他片为受试制剂,按生物等效性试验的有关规定,与小野药品工业株式会社生产的依帕司他片(商品名:KINEDAK®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂依帕司他片和参比制剂依帕司他片(KINEDAK®)在健康受试者中的安全性。
[Translation] Main purpose: Using epalrestat tablets provided by China Resources Zizhu Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of epalrestat tablets (trade name: KINEDAK®, reference preparation) produced by Ono Pharmaceutical Co., Ltd. were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation epalrestat tablets and the reference preparation epalrestat tablets (KINEDAK®) in healthy subjects.