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一项在健康受试者中评估HY-0902片安全性、耐受性和药代动力学的随机、双盲、安慰剂对照的I期临床研究
[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of HY-0902 tablets in healthy subjects
主要目的:
评价在健康受试者中单次、多次口服HY-0902片后的安全性、耐受性。
次要目的:
评价在健康受试者中单次、多次口服HY-0902片后的药代动力学特征;评价食物对HY-0902片药代动力学的影响及餐后状态下口服HY-0902片的安全性和耐受性。
[Translation] Primary purpose:
To evaluate the safety and tolerability of HY-0902 tablets after single and multiple oral administration in healthy subjects.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of HY-0902 tablets after single and multiple oral administration in healthy subjects; to evaluate the effect of food on the pharmacokinetics of HY-0902 tablets and the safety and tolerability of oral administration of HY-0902 tablets in the postprandial state.
[Translation] Study on the bioequivalence of vardenafil hydrochloride tablets in healthy volunteers
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] Healthy Chinese subjects were used as test subjects. A self-cross-controlled experimental design was adopted to determine the time course of plasma concentration of vardenafil hydrochloride in healthy subjects after oral administration of vardenafil hydrochloride tablets licensed by Shandong Haiya Pharmaceutical Technology Co., Ltd. and produced by Nanjing Haina Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Vardenafil hydrochloride tablets [trade name: Aili Da®] licensed by Bayer AG were used as reference to investigate the bioavailability of the test preparation, evaluate the bioequivalence between preparations, and observe the safety of vardenafil hydrochloride tablets in healthy Chinese subjects.
100 Clinical Results associated with Shandong Haiya Medical Technology Co., Ltd.
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