比索洛尔氨氯地平片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of bisoprolol and amlodipine tablets in humans under fasting and fed conditions
考察空腹及餐后条件下,健康受试者单次口服由宁波美诺华天康药业有限公司生产,宁波科尔康美诺华药业有限公司提供的比索洛尔氨氯地平片【受试制剂,规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg】与相同条件下单次口服由Merck Kft持证的比索洛尔氨氯地平片【参比制剂,规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)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 bisoprolol amlodipine tablets [test preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] produced by Ningbo Minopharm Tiankang Pharmaceutical Co., Ltd. and provided by Ningbo Keerkang Minopharm Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions, and a single oral administration of bisoprolol amlodipine tablets [reference preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] certified by Merck Kft under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
甲苯磺酸艾多沙班片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of edoxaban tosylate tablets in humans under fasting and fed conditions
本研究考察健康受试者在空腹及餐后条件下,单次口服由宁波美诺华天康药业有限公司生产,宁波科尔康美诺华药业有限公司提供的甲苯磺酸艾多沙班片(受试制剂,规格:30 mg)或由Daiichi Sankyo Europe GmbH持证的甲苯磺酸艾多沙班片(参比制剂,商品名:里先安®,规格:30 mg)的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] This study investigated the pharmacokinetic characteristics of edoxaban tosylate tablets (test preparation, strength: 30 mg) produced by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. and provided by Ningbo Keerkang Minova Pharmaceutical Co., Ltd. or edoxaban tosylate tablets (reference preparation, trade name: Lixianan®, strength: 30 mg) certified by Daiichi Sankyo Europe GmbH in healthy subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations to provide a basis for the registration application of the test preparation.
[Translation] Human bioequivalence study of fed and fasting administration
主要目的:本试验旨在研究单次空腹和餐后口服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。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study aims 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 single fasting and postprandial oral administration; pantoprazole sodium enteric-coated tablets (Pantoloc®, 40 mg) produced by Takeda GmbH Production Site Oranienburg were 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.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
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