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雷马曲班片在中国健康志愿者中进行的人体生物等效性预试验
[Translation] A pilot human bioequivalence study of Lematroban tablets in Chinese healthy volunteers
主要目的:观察中国健康志愿者在空腹/餐后服用受试制剂雷马曲班片(规格:75mg;生产企业:瑞阳制药有限公司)和参比制剂雷马曲班片(规格:75mg;生产企业:日本拜耳药品株式会社)后的药代动力学特征,评价空腹/餐后两种制剂的生物等效性。
次要目的:观察受试制剂雷马曲班片和参比制剂雷马曲班片在中国健康志愿者中的安全性
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Ramaquban tablets (specification: 75 mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and the reference preparation Ramaquban tablets (specification: 75 mg; manufacturer: Bayer Pharmaceuticals Co., Ltd., Japan) in healthy Chinese volunteers after taking them on an empty stomach/after meals, and to evaluate the bioequivalence of the two preparations on an empty stomach/after meals.
Secondary objective: To observe the safety of the test preparation Ramaquban tablets and the reference preparation Ramaquban tablets in healthy Chinese volunteers
雷马曲班片在中国健康志愿者中进行的人体生物等效性预试验
[Translation] A pilot human bioequivalence study of Lematroban tablets in Chinese healthy volunteers
主要目的:观察中国健康志愿者在空腹/餐后服用受试制剂雷马曲班片(规格:50mg;生产企业:瑞阳制药有限公司)和参比制剂雷马曲班片(规格:50mg;生产企业:日本拜耳药品株式会社)后的药代动力学特征,评价空腹/餐后两种制剂的生物等效性。
次要目的:观察受试制剂雷马曲班片和参比制剂雷马曲班片在中国健康志愿者中的安全性
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Ramaquban tablets (specification: 50 mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and the reference preparation Ramaquban tablets (specification: 50 mg; manufacturer: Bayer Pharmaceuticals Co., Ltd., Japan) in healthy Chinese volunteers after taking them on an empty stomach/after meals, and to evaluate the bioequivalence of the two preparations on an empty stomach/after meals.
Secondary objective: To observe the safety of the test preparation Ramaquban tablets and the reference preparation Ramaquban tablets in healthy Chinese volunteers
盐酸氯卡色林片在中国健康受试者中进行的人体生物等效性预试验
[Translation] A pilot human bioequivalence study of lorcaserin hydrochloride tablets in healthy Chinese subjects
初步观察中国健康受试者在空腹状态下单次口服受试制剂盐酸氯卡色林片(规格:10mg;生产企业:瑞阳制药有限公司)和参比制剂盐酸氯卡色林片(商品名:BELVIQ®;规格:10mg;生产企业:EISAI INC)后的药代动力学特征,进行药代动力学关键参数的比较;为正式试验提供研究依据。
[Translation] To preliminarily observe the pharmacokinetic characteristics of the test preparation lorcaserin hydrochloride tablets (specification: 10 mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and the reference preparation lorcaserin hydrochloride tablets (trade name: BELVIQ®; specification: 10 mg; manufacturer: EISAI INC) after a single oral administration in Chinese healthy subjects in the fasting state, and compare the key pharmacokinetic parameters; to provide research basis for formal trials.
100 Clinical Results associated with Beijing Rundekang Medical Tech. Co., Ltd.
0 Patents (Medical) associated with Beijing Rundekang Medical Tech. Co., Ltd.
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100 Translational Medicine associated with Beijing Rundekang Medical Tech. Co., Ltd.