[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of Pemabet tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂佩玛贝特片(规格:0.1mg)和参比制剂佩玛贝特片(商品名:PARMODIA®;规格:0.1mg;持证商:興和株式会社)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。。
次要目的:观察受试制剂佩玛贝特片和参比制剂佩玛贝特片(PARMODIA®)在中国健康受试者中的安全性。
[Translation] Main purpose: To observe the single oral administration of the test preparation Pemafibrate tablets (specification: 0.1mg) and the reference preparation Pemafibrate tablets (trade name: PARMODIA®; specifications) to Chinese healthy subjects in the fasting/postprandial state. : 0.1 mg; license holder: Kowa Co., Ltd.) to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. .
Secondary purpose: To observe the safety of the test preparation pemafibrate tablets and the reference preparation pemafibrate tablets (PARMODIA®) in Chinese healthy subjects.