[Translation] Bioequivalence study of oseltamivir phosphate capsules in humans
主要研究目的:在空腹及餐后状态下的中国健康受试者中,以原研:上市许可持有人为Roche Registration Ltd.生产企业Delpharm Milano S.r.l.生产,上海罗氏制药分装的磷酸奥司他韦胶囊(规格:75mg)作为参比制剂,以湖州海王健康产业发展有限公司生产的磷酸奥司他韦胶囊(规格:75mg)作为受试制剂,研究单剂量口服磷酸奥司他韦胶囊后奥司他韦和活性代谢产物奥司他韦羧酸在体内的经时过程,计算其药代动力学参数,比较两种制剂的相对生物利用度,评价两者的人体生物等效性。次要目的:观察和评价空腹和餐后单剂量口服受试制剂的相对生物利用度,评价两者的人体生物等效性。
[Translation] The main purpose of the study is to study the time course of oseltamivir and its active metabolite oseltamivir carboxylic acid in the body after a single oral dose of oseltamivir phosphate capsules in healthy Chinese subjects in the fasting and postprandial states, using oseltamivir phosphate capsules (specification: 75 mg) produced by Delpharm Milano S.r.l., the original research and marketing authorization holder, Roche Registration Ltd., and packaged by Shanghai Roche Pharmaceuticals as the reference preparation, and oseltamivir phosphate capsules (specification: 75 mg) produced by Huzhou Haiwang Health Industry Development Co., Ltd. as the test preparation, to calculate their pharmacokinetic parameters, compare the relative bioavailability of the two preparations, and evaluate the human bioequivalence of the two. Secondary purpose: to observe and evaluate the relative bioavailability of the single oral dose of the test preparation after fasting and postprandial administration, and evaluate the human bioequivalence of the two.
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