[Translation] Single-dose, randomized, open-label, crossover, two-period fasting and fed human bioequivalence studies of Pemafibrate tablets in healthy study participants
主要目的:以南京海鲸药业股份有限公司的佩玛贝特片(规格:0.1mg)为受试制剂,以兴和株式会社的佩玛贝特片(规格:0.1mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] Main purpose: take Pemafibrate Tablets (specification: 0.1mg) of Nanjing Haijing Pharmaceutical Co., Ltd. as the test preparation, and take Pemafibrate Tablets (specification: 0.1mg) of Xinghe Co., Ltd. as the reference preparation According to the relevant regulations of bioequivalence test, the bioequivalence of the two preparations in healthy human body was investigated.
Secondary objective: To observe the safety of the test and reference formulations in healthy study participants.