[Translation] Human bioequivalence test of valsartan capsules 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] Under fasting conditions, healthy subjects took a single oral administration of valsartan capsules (test preparation T, specification: 80 mg) produced by Beijing Enze Jiashi Pharmaceutical Co., Ltd. and a single oral administration of valsartan capsules produced by Beijing Novartis Pharmaceuticals Co., Ltd. Pharmacokinetic characteristics of Tan capsules (reference preparation R, trade name: Diovan, specification: 80 mg), evaluate the bioequivalence and safety between the two preparations, and provide a basis for the registration application of the test preparation.
[Translation] Human bioequivalence test of valsartan capsules under postprandial 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] Under postprandial conditions, healthy subjects took a single oral administration of valsartan capsules (test preparation T, specification: 80 mg) produced by Beijing Enze Jiashi Pharmaceutical Co., Ltd. and a single oral administration of valsartan capsules produced by Beijing Novartis Pharmaceuticals Co., Ltd. Pharmacokinetic characteristics of Sartan capsules (reference preparation R, trade name: Diovan, specification: 80 mg), evaluate the bioequivalence and safety between the two preparations, and provide a basis for the registration application of the test preparation.
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