/ Active, not recruitingNot Applicable 达格列净二甲双胍缓释片（10mg/1000mg） 在餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of dapagliflozin and metformin extended-release tablets (10 mg/1000 mg) in humans 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达格列净二甲双胍缓释片（受试制剂，规格：10mg达格列净/1000mg盐酸二甲双胍）与单次口服由AstraZeneca AB持证的达格列净二甲双胍缓释片（参比制剂，商品名：Xigduo®XR，规格：10mg达格列净/1000mg盐酸二甲双胍）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 dapagliflozin metformin extended-release tablets (test preparation, specification: 10 mg dapagliflozin/1000 mg metformin hydrochloride) provided by Ningbo Keer Kangmei Novartis Pharmaceuticals Co., Ltd. and a single oral administration of dapagliflozin metformin extended-release tablets (reference preparation, trade name: Xigduo® XR, specification: 10 mg dapagliflozin/1000 mg metformin hydrochloride) certified by AstraZeneca AB under postprandial conditions in healthy subjects, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
/ Active, not recruitingNot Applicable 达格列净二甲双胍缓释片（10mg/1000mg） 在空腹条件下的人体生物等效性试验
[Translation] Bioequivalence study of dapagliflozin and metformin extended-release tablets (10 mg/1000 mg) in humans 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达格列净二甲双胍缓释片（受试制剂，规格：10mg达格列净/1000mg盐酸二甲双胍）与单次口服由AstraZeneca AB持证的达格列净二甲双胍缓释片（参比制剂，商品名：Xigduo®XR，规格：10mg达格列净/1000mg盐酸二甲双胍）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 dapagliflozin metformin extended-release tablets (test preparation, specification: 10 mg dapagliflozin/1000 mg metformin hydrochloride) provided by Ningbo Keer Kangmei Novartis Pharmaceuticals Co., Ltd. and a single oral administration of dapagliflozin metformin extended-release tablets (reference preparation, trade name: Xigduo® XR, specification: 10 mg dapagliflozin/1000 mg metformin hydrochloride) certified by AstraZeneca AB 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.
/ RecruitingNot Applicable [Translation] Study on the bioequivalence of ilaprazole enteric-coated tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服宁波科尔康美诺华药业有限公司研制、宁波美诺华天康药业有限公司生产的艾普拉唑肠溶片（5 mg）的药代动力学特征；以丽珠集团丽珠制药厂持证、生产的艾普拉唑肠溶片（壹丽安®，5 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，并观察两制剂在健康受试者中的安全性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of ilaprazole enteric-coated tablets (5 mg) developed by Ningbo Keerkang Minova Pharmaceutical Co., Ltd. and produced by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using ilaprazole enteric-coated tablets (Yilian®, 5 mg) certified and produced by Livzon Pharmaceutical Factory of Livzon Group as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy subjects was observed.
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.
