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MechanismSodium channels blockers |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date11 Mar 1955 |
/ Not yet recruitingNot ApplicableIIT Effects of Bifid.Triple Viable Capsules Dissolving at Intestines on defecation, quality of life and gut microbiota in patients with functional constipation: A randomized, double-blind, placebo-controlled clinical study
/ CompletedNot Applicable [Translation] Study on the bioequivalence of rabeprazole sodium enteric-coated tablets in healthy volunteers
本试验旨在研究单次空腹口服晋城海斯制药有限公司研制、生产的雷贝拉唑钠肠溶片(20 mg)的药代动力学特征;以卫材(中国)药业有限公司生产的雷贝拉唑钠肠溶片(波利特®,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。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of a single fasting oral administration of rabeprazole sodium enteric-coated tablets (20 mg) developed and produced by Jincheng Haisi Pharmaceutical Co., Ltd.; using rabeprazole sodium enteric-coated tablets (Polite®, 20 mg) produced by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of rabeprazole sodium enteric-coated tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服晋城海斯制药有限公司研制、生产的雷贝拉唑钠肠溶片(20 mg)的药代动力学特征;以卫材(中国)药业有限公司生产的雷贝拉唑钠肠溶片(波利特®,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。
[Translation] The aim of this study was to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral administration of rabeprazole sodium enteric-coated tablets (20 mg) developed and produced by Jincheng Haisi Pharmaceutical Co., Ltd.; using rabeprazole sodium enteric-coated tablets (Polite®, 20 mg) produced by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Jincheng Haisi Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Jincheng Haisi Pharmaceutical Co. Ltd.
100 Deals associated with Jincheng Haisi Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Jincheng Haisi Pharmaceutical Co. Ltd.