[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, double-crossover, fasting bioequivalence study of epalrestat tablets in healthy Chinese subjects
主要研究目的
本试验以石家庄康力药业有限公司生产的依帕司他片(规格:50 mg)为受试制剂,以アルフレッサファーマ株式会社(Alfresa Pharma Corporation)生产的依帕司他片(KINEDAK®,50 mg)为参比制剂,评估受试制剂和参比制剂在空腹条件下的生物等效性。
次要研究目的
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main study objectives
This study used epalrestat tablets (specification: 50 mg) produced by Shijiazhuang Kangli Pharmaceutical Co., Ltd. as the test preparation and epalrestat tablets (KINEDAK®, 50 mg) produced by Alfresa Pharma Corporation as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting conditions.
Secondary study objectives
To observe the safety of the test preparation and the reference preparation in healthy subjects.