随机、开放、单剂量、两制剂、交叉对照设计,评价中国健康受试者在空腹及餐后状态下单次口服尼可地尔片后的生物等效性正式试验
[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled study to evaluate the bioequivalence of a single oral dose of nicorandil tablets in Chinese healthy subjects in the fasting and fed state
以杭州志呈科技有限公司提供的尼可地尔片为受试制剂,按生物等效性试验的有关规定,与Chugai Pharmaceutical Co.,Ltd持证的尼可地尔片(商品名:Sigmart®/喜格迈®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性, 为该药注册申报和临床应用提供参考依据。
[Translation] Nicorandil tablets provided by Hangzhou Zhicheng Technology Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of Nicorandil tablets (trade name: Sigmart®/Sigma®, reference preparation) certified by Chugai Pharmaceutical Co., Ltd. were compared in healthy humans, and the bioequivalence of the two preparations was investigated to provide a reference for the registration and clinical application of the drug.
100 Clinical Results associated with Hangzhou Zhicheng Technology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Zhicheng Technology Co., Ltd.
100 Deals associated with Hangzhou Zhicheng Technology Co., Ltd.
100 Translational Medicine associated with Hangzhou Zhicheng Technology Co., Ltd.