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MechanismProton pump inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date14 Oct 1997 |
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] Human Bioequivalence Study of Avatrombopag Maleate Tablets (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] The purpose of this experiment is to study the pharmacokinetic characteristics of avatrombopag maleate tablets (20 mg) developed and produced by Hunan Mingrui Pharmaceutical Co., Ltd. after a single meal; Avatrombopag maleate tablets (Sukexin®, 20 mg) produced by Eisai Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared, and the two preparations were evaluated. The human bioequivalence of the formulations and the safety of the two formulations in healthy subjects were observed.
[Translation] Human Bioequivalence Study of Avatrombopag Maleate Tablets (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] The purpose of this study is to study the pharmacokinetic characteristics of avatrombopag maleate tablets (20 mg) developed and produced by Hunan Mingrui Pharmaceutical Co., Ltd. after a single fasting oral administration. Co., Ltd. produced Avatrombopag Maleate Tablets (Su Kexin®, 20 mg) as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared, and the two preparations were evaluated. bioequivalence in humans, and observed the safety of the two preparations in healthy subjects.
[Translation] Study on human pharmacokinetics of Caomuxiliu infusion tablets
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 experiment was to study the pharmacokinetic characteristics of the herbal infusion tablets (400 mg (containing 25 mg of herbal infusion), developed and produced by Hunan Mingrui Pharmaceutical Co., Ltd. after a single fasting oral administration; The herbal infusion tablets [Xiaoduzhi-M®, 400 mg (contains 25 mg of herbal infusions)] produced by Nursery Co., Ltd. were the reference preparations, and the pharmacokinetic parameters Cmax and AUC0-t of the two preparations were compared. , AUC0-∞.
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.