[Translation] Bioequivalence study of candecitabine tablets in human subjects under fed conditions
考察餐后条件下，健康受试者单次口服由宁波科尔康美诺华药业有限公司提供的坎地氢噻片（受试制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）与单次口服由CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（参比制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）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 candesartan cilexetil tablets (test preparation, specification: each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide) provided by Ningbo Keer Kangmei Novartis Pharmaceuticals Co., Ltd. and candesartan cilexetil tablets (reference preparation, specification: each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide) certified by CHEPLAPHARM Arzneimittel GmbH in healthy subjects after a single oral administration under postprandial conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
[Translation] Bioequivalence study of candecitabine tablets in human subjects under fasting conditions
考察空腹条件下，健康受试者单次口服由宁波科尔康美诺华药业有限公司提供的坎地氢噻片（受试制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）与单次口服由CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（参比制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）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 Candesartan cilexetil tablets (test preparation, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) provided by Ningbo Keer Kangmei Novartis Pharmaceutical Co., Ltd. and a single oral administration of Candesartan cilexetil tablets (reference preparation, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) certified by CHEPLAPHARM Arzneimittel GmbH in healthy subjects under fasting conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
[Translation] Study on the bioequivalence of pantoprazole sodium enteric-coated tablets in healthy volunteers
本试验旨在研究单次空腹口服 Krka, d. d., Novo mesto, Slovenia, EU 研制、生产的泮托拉唑钠肠溶片（40 mg）的药代动力学特征；以 Takeda GmbH Production Site Oranienburg 生产的泮托拉唑钠肠溶片（Pantoloc®，40 mg）为参比制剂，比较两制剂中药动学参数 Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性
[Translation] The aim of this study was to investigate the pharmacokinetic characteristics of pantoprazole sodium enteric-coated tablets (40 mg) developed and produced by Krka, d. d., Novo mesto, Slovenia, EU after a single fasting oral administration; pantoprazole sodium enteric-coated tablets (Pantoloc®, 40 mg) produced by Takeda GmbH Production Site Oranienburg was used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Ningbo Krka Menovo Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Ningbo Krka Menovo Pharmaceutical Co., Ltd.
100 Deals associated with Ningbo Krka Menovo Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Ningbo Krka Menovo Pharmaceutical Co., Ltd.
