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[Translation] Bioequivalence study of vardenafil hydrochloride tablets in humans
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定山东海雅医药科技有限公司持证,南京海纳制药有限公司生产的盐酸伐地那非片口服给药后,盐酸伐地那非在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以Bayer AG持证生产的盐酸伐地那非片[商品名:艾力达®]为参比,考察受试制剂的生物利用度,评价制剂间的生物等效性,并观察盐酸伐地那非片在中国健康受试者中的安全性。
[Translation] Taking Chinese healthy subjects as the test subjects, the self-cross-control experimental design was used to determine the vardenafil hydrochloride tablets produced by Shandong Haiya Pharmaceutical Technology Co., Ltd. and Nanjing Haina Pharmaceutical Co., Ltd. after oral administration. The time course of the plasma concentration of denafil in healthy subjects, the corresponding pharmacokinetic parameters were estimated, and the vardenafil hydrochloride tablets [trade name: Elida®] produced by Bayer AG with license were used as the For reference, the bioavailability of the test preparations was investigated, the bioequivalence between the preparations was evaluated, and the safety of vardenafil hydrochloride tablets in Chinese healthy subjects was observed.
100 Clinical Results associated with Shandong Haiya Medical Technology Co., Ltd.
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