[Translation] Single-center, randomized, open-label, single-dose, two-cycle, two-sequence, double-crossover bioequivalence study of Vonola fumarate raw tablets 20mg in fasting and postprandial states
主要研究目的
研究受试制剂富马酸伏诺拉生片(规格:20mg,生产厂家:宜昌人福药业有限责任公司)和参比制剂富马酸沃诺拉赞片(商品名:Takecab,规格:20mg生产厂家:武田薬品工業株式会社)在健康受试者空腹和餐后状态下单剂量给药时的药代动力学特征,并评价两制剂的人体生物等效性。
次要研究目的
观察受试制剂富马酸伏诺拉生片和参比制剂Takecab在健康受试者中的安全性。
[Translation] Main research purpose
The research and test preparation vornorazan fumarate tablets (specification: 20mg, manufacturer: Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation vornorazan fumarate tablets (trade name: Takecab, specification: 20mg Manufacturer: Takeda Yashin Kogyo Co., Ltd.) pharmacokinetic characteristics of single-dose administration in healthy subjects in fasting and postprandial states, and evaluation of the human bioequivalence of the two preparations.
Secondary research purpose
To observe the safety of the test preparation Vonola fumarate and the reference preparation Takecab in healthy subjects.