/ Active, not recruitingNot Applicable 麦考酚钠肠溶片在健康受试者中的单剂量、随机、开放、两制剂、重复交叉、四周期、空腹和餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, two-dose, repeated crossover, four-period, fasting and fed human bioequivalence study of mycophenolate sodium enteric-coated tablets in healthy subjects
主要目的:以重庆迈川医药科技有限公司的麦考酚钠肠溶片(规格:以麦考酚酸((C17H20O6)计0.18g)为受试制剂,以诺华制药(Novartis Pharma GmbH)的麦考酚钠肠溶片(商品名:Myfortic®/米芙®,规格:180mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Using the Mycophenol Sodium Enteric-coated Tablets (specification: 0.18 g based on mycophenolic acid ((C17H20O6)) of Chongqing Maichuan Pharmaceutical Technology Co., Ltd. as the test preparation and the Mycophenol Sodium Enteric-coated Tablets (trade name: Myfortic®/Mifu®, specification: 180 mg) of Novartis Pharma GmbH as the reference preparation, the bioequivalence of the two preparations in healthy humans was investigated according to the relevant provisions of the bioequivalence test.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Chongqing Maichuan Medical Technology Co., Ltd.
0 Patents (Medical) associated with Chongqing Maichuan Medical Technology Co., Ltd.
100 Deals associated with Chongqing Maichuan Medical Technology Co., Ltd.
100 Translational Medicine associated with Chongqing Maichuan Medical Technology Co., Ltd.