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MechanismProton pump inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date19 Aug 1999 |
Target- |
Mechanism- |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date21 Dec 1979 |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date05 Jul 1967 |
[Translation] Bioequivalence study of avatrombopag maleate tablets in humans (postprandial test)
本试验旨在研究单次餐后口服湖南明瑞制药有限公司研制、生产的马来酸阿伐曲泊帕片(20 mg)的药代动力学特征;以AkaRx Inc.持证、Kawashima Plant, Eisai Co.,Ltd.生产的马来酸阿伐曲泊帕片(苏可欣®,20 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 aims to study the pharmacokinetic characteristics of avatrombopag maleate tablets (20 mg) developed and produced by Hunan Mingrui Pharmaceutical Co., Ltd. after a single oral administration after meal; using avatrombopag maleate tablets (Sukoxin®, 20 mg) certified by AkaRx Inc. and produced by Kawashima Plant, Eisai Co., Ltd. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy subjects.
[Translation] Bioequivalence study of avatrombopag maleate tablets in humans (fasting test)
本试验旨在研究单次空腹口服湖南明瑞制药有限公司研制、生产的马来酸阿伐曲泊帕片(20 mg)的药代动力学特征;以AkaRx Inc.持证、Kawashima Plant, Eisai Co.,Ltd.生产的马来酸阿伐曲泊帕片(苏可欣®,20 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 aims to study the pharmacokinetic characteristics of a single fasting oral dose of avatrombopag maleate tablets (20 mg) developed and produced by Hunan Mingrui Pharmaceutical Co., Ltd.; using avatrombopag maleate tablets (Sukoxin®, 20 mg) certified by AkaRx Inc. and produced by Kawashima Plant, Eisai Co., Ltd. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy subjects.
[Translation] Study on the pharmacokinetics of Melilotifolia infusion tablets in healthy volunteers
本试验旨在研究单次空腹口服湖南明瑞制药有限公司研制、生产的草木犀流浸液片〔400 mg(含草木犀流浸液25 mg)〕的药代动力学特征;以生晃荣养药品株式会社生产的草木犀流浸液片〔消脱止-M®,400 mg(含草木犀流浸液25 mg)〕为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of a single oral fasting dose of Mesorhizium oxyphylla fluid infusion tablets (400 mg (containing Mesorhizium oxyphylla fluid infusion 25 mg)) developed and produced by Hunan Mingrui Pharmaceutical Co., Ltd.; using Mesorhizium oxyphylla fluid infusion tablets (Xiaoduozhi-M®, 400 mg (containing Mesorhizium oxyphylla fluid infusion 25 mg)) produced by Shenghuang Rongyang Pharmaceutical Co., Ltd. as the reference preparation, and to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations.
100 Clinical Results associated with Hunan Mingrui Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Hunan Mingrui Pharmaceutical Co. Ltd.
100 Deals associated with Hunan Mingrui Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Hunan Mingrui Pharmaceutical Co. Ltd.