[Translation] Bioequivalence study of valsartan capsules in humans under fasting conditions
考察空腹条件下,健康受试者单次口服由北京恩泽嘉事制药有限公司生产的缬沙坦胶囊(受试制剂T,规格:80mg)与单次口服由北京诺华制药有限公司生产的缬沙坦胶囊(参比制剂R,商品名:代文,规格:80mg)的药动学特征,评价两制剂间的生物等效性及安全性,为受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of valsartan capsules produced by Beijing Enze Jiashi Pharmaceutical Co., Ltd. (test preparation T, specification: 80 mg) and a single oral administration of valsartan capsules produced by Beijing Novartis Pharmaceuticals Co., Ltd. (reference preparation R, trade name: Diovan, specification: 80 mg) in healthy subjects under fasting conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
[Translation] Bioequivalence study of valsartan capsules in humans under fed conditions
考察餐后条件下,健康受试者单次口服由北京恩泽嘉事制药有限公司生产的缬沙坦胶囊(受试制剂T,规格:80mg)与单次口服由北京诺华制药有限公司生产的缬沙坦胶囊(参比制剂R,商品名:代文,规格:80mg)的药动学特征,评价两制剂间的生物等效性及安全性,为受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of valsartan capsules (test preparation T, specification: 80 mg) produced by Beijing Enze Jiashi Pharmaceutical Co., Ltd. and valsartan capsules (reference preparation R, trade name: Diovan, specification: 80 mg) produced by Beijing Novartis Pharmaceuticals Co., Ltd. in healthy subjects after a single oral administration under postprandial conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
100 Clinical Results associated with Beijing Enze Jiashi Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Beijing Enze Jiashi Pharmaceutical Co., Ltd.
100 Deals associated with Beijing Enze Jiashi Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Beijing Enze Jiashi Pharmaceutical Co., Ltd.