[Translation] Randomized, open-label, two-dose, two-cycle, crossover, fasting and postprandial bioequivalence study of bicalutamide tablets in healthy humans
主要目的:以上海复旦复华药业有限公司提供的比卡鲁胺片为受试制剂,按照有关生物等效性试验规定,与AstraZeneca UK Limited生产的比卡鲁胺片(商品名:康士得®,参比制剂)进行空腹及餐后状态下人体生物利用度与生物等效性试验。
次要目的:观察受试制剂比卡鲁胺片和参比制剂(康士得®)比卡鲁胺片在健康受试者中的安全性。
[Translation] Main purpose: Take bicalutamide tablets provided by Shanghai Fudan Fuhua Pharmaceutical Co., Ltd. as the test preparation, in accordance with the relevant bioequivalence test regulations, and Bicalutamide tablets (trade name: Kangshida) produced by AstraZeneca UK Limited. ®, reference preparation) for human bioavailability and bioequivalence tests in fasting and postprandial states.
Secondary objective: To observe the safety of the test preparation Bicalutamide Tablets and the reference preparation (Costride®) Bicalutamide Tablets in healthy subjects.