/ RecruitingNot Applicable 美阿沙坦钾片在中国健康受试者中进行的单中心、随机、开放、单次(空腹/餐后)口服给
药、两制剂、两序列、两周期、交叉的人体生物等效性试验
[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of Asartan Potassium Tablets in healthy Chinese subjects.
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂美阿沙坦钾片(规格:按美阿沙坦(C30H24N4O8)计 80mg;生产企业:石家庄格瑞药业有限公司)和参比制剂美阿沙坦钾片(商品名:易达比(EDARBI);规格:按美阿沙坦(C30H24N4O8)计 80mg;持证商:Takeda Pharma A/S)后的药代动力学特征,评价空腹/餐后状态下两种制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂美阿沙坦钾片和参比制剂美阿沙坦钾片(易达比(EDARBI))在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg based on Asartan (C30H24N4O8); Manufacturer: Shijiazhuang Grey Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (Trade name: EDARBI; Specification: 80 mg based on Asartan (C30H24N4O8); Licensee: Takeda Pharma A/S) in healthy Chinese subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in healthy subjects in the fasting/fed state.
Secondary objective: To observe the safety of the test preparation, Asartan Potassium Tablets and the reference preparation, Asartan Potassium Tablets (EDARBI) in healthy Chinese subjects.
/ CompletedNot Applicable 一项单中心、随机开放、双周期自身交叉、单剂量给药评价盐酸阿罗洛尔片在中国健康人群的生物等效性试验
[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose study to evaluate the bioequivalence of arotinolol hydrochloride tablets in healthy Chinese subjects
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹和餐后给药条件下,石家庄格瑞药业有限公司生产的盐酸阿罗洛尔片(10 mg/片)与Sumitomo Dainippon Pharma Co.,Ltd.生产的盐酸阿罗洛尔片(10 mg/片,商品名:阿尔马尔®)在中国健康人群吸收程度和吸收速度的差异,并评价石家庄格瑞药业有限公司生产的盐酸阿罗洛尔片的安全性和耐受性。
[Translation] A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in the extent and rate of absorption of arotinolol hydrochloride tablets (10 mg/tablet) produced by Shijiazhuang Grey Pharmaceutical Co., Ltd. and arotinolol hydrochloride tablets (10 mg/tablet, trade name: ALMARE®) produced by Sumitomo Dainippon Pharma Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety and tolerability of arotinolol hydrochloride tablets produced by Shijiazhuang Grey Pharmaceutical Co., Ltd.
/ Not yet recruitingNot Applicable 普罗布考片在健康受试者中随机、开放、单次给药、三周期、部分重复空腹/餐后状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, three-period, partially repeated bioequivalence study of probucol tablets in healthy subjects under fasting/fed conditions
主要研究目的:研究空腹/餐后状态下单次口服受试制剂普罗布考片(规格:0.25g,石家庄格瑞药业有限公司持证)与参比制剂普罗布考片(商品名:Lorelco®,规格:0.25g;大塚製薬株式会社持证)在健康成年受试者体内的生物等效性。
次要研究目的:研究受试制剂和参比制剂在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the bioequivalence of the test preparation Probucol Tablets (Specification: 0.25g, licensed by Shijiazhuang Grey Pharmaceutical Co., Ltd.) and the reference preparation Probucol Tablets (Trade name: Lorelco®, Specification: 0.25g; licensed by Otsuka Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting/postprandial state.
The secondary purpose of the study is to study the safety of the test preparation and the reference preparation in healthy adult subjects.
100 Clinical Results associated with Shi Jiazhuang Great Pharmaceutical Co.,Ltd
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