[Translation] A randomized, open-label, single-dose, two-period, self-crossover, bioequivalence study of Pemabet tablets in healthy study participants under fasting and fed conditions
主要目的:
以广州一品红制药有限公司生产的佩玛贝特片(规格:0.1 mg)为受试制剂,按生物等效性试验的有关规定,与興和株式会社持证的佩玛贝特片(参比制剂,商品名:Parmodia®,规格:0.1 mg)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要目的:
观察佩玛贝特片受试制剂(规格:0.1 mg)和参比制剂(商品名:Parmodia ®,规格:0.1 mg)在健康研究参与者中的安全性。
[Translation] Main purpose:
Pemabet tablets (specification: 0.1 mg) produced by Guangzhou Yipinhong Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the relative bioavailability in healthy humans was compared with that of Pemabet tablets (reference preparation, trade name: Parmodia®, specification: 0.1 mg) certified by Kowa Co., Ltd. to investigate the human bioequivalence of the two preparations.
Secondary Purpose:
To observe the safety of the test formulation of Pemabet tablets (strength: 0.1 mg) and the reference formulation (trade name: Parmodia ®, strength: 0.1 mg) in healthy study participants.