[Translation] Anhui Meilai Pharmaceutical Co., Ltd.'s Pemafibrate tablets and Xinghe Co., Ltd.'s Pemafibrate tablets (trade name: PARMODIA®) were randomized, open-label, single-dose, and two-dose trials in healthy subjects in a single center. Bioequivalence studies in cyclic, double-crossover, fasting and postprandial states.
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定受试制剂佩玛贝特片给药后血浆中的佩玛贝特在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以興和株式会社持证生产的佩玛贝特片(商品名:PARMODIA®,规格:0.1 mg)为参比,评价制剂间的生物等效性,并观察佩玛贝特片在中国健康受试者中的安全性。
[Translation] Taking Chinese healthy subjects as the test subjects, a self-cross-control experimental design was adopted to measure the time course of the blood concentration of pemafibrate in the plasma of healthy subjects after administration of the test preparation pemafibrate tablets. , estimate the corresponding pharmacokinetic parameters, and use Pemafibrate tablets (trade name: PARMODIA®, specification: 0.1 mg) produced by Xinghe Co., Ltd. with a license as a reference to evaluate the bioequivalence between preparations. And observe the safety of Pemafibrate tablets in Chinese healthy subjects.