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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] Human Bioequivalence Preliminary Trial of Rematroban 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] Main purpose: To observe Chinese healthy volunteers taking test preparation Rematroban tablets (specification: 75mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and reference preparation Rematroban tablets (specification: 75mg; Manufacturer: Bayer Pharmaceuticals Co., Ltd., Japan), and evaluate the bioequivalence of the two preparations after fasting/meal.
Secondary objective: To observe the safety of test preparation Rematroban Tablets and reference preparation Rematroban Tablets in Chinese healthy 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] Human Bioequivalence Preliminary Trial of Rematroban 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] Main purpose: To observe Chinese healthy volunteers taking test preparation Rematroban tablets (specification: 50mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and reference preparation Rematroban tablets (specification: 50mg; Manufacturer: Bayer Pharmaceutical Co., Ltd., Japan), and evaluate the bioequivalence of the two preparations after fasting/meal.
Secondary objective: To observe the safety of test preparation Rematroban Tablets and reference preparation Rematroban Tablets in Chinese healthy 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] Human Bioequivalence Preliminary Trial of Lorcaserin Hydrochloride Tablets in Chinese Healthy 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] Preliminary observation of Chinese healthy subjects taking a single oral dose of test preparation lorcaserin hydrochloride tablets (specification: 10 mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and reference preparation lorcaserin hydrochloride tablets (trade name) in fasting state. : BELVIQ®; Specification: 10mg; Manufacturer: EISAI INC) after the pharmacokinetic characteristics, to compare the key parameters of pharmacokinetics; to provide research basis for formal trials.
100 Clinical Results associated with Beijing Rundekang Medical Tech Co Ltd
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