/ 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.
/ CompletedNot Applicable [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.
/ CompletedNot Applicable [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.
100 Clinical Results associated with Ningbo Krka Menovo Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Ningbo Krka Menovo Pharmaceutical Co., Ltd.
