[Translation] A randomized, open-label, fasting single-dose, two-agent, two-sequence, two-cycle crossover bioequivalence study of epalrestat tablets in Chinese adult healthy 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: Take epalrestat tablets provided by China Resources Zizhu Pharmaceutical Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence test, and the epalrestat tablets (trade name: KINEDAK) produced by Ono Pharmaceutical Industry Co., Ltd. ®, reference preparation) to compare the absorption rate and degree of absorption in healthy humans, and to investigate the human bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation Epalrestat Tablets and the reference preparation Epalrestat Tablets (KINEDAK®) in healthy subjects.