[Translation] A single-center, open-label, randomized, single-dose, two-dose, four-period, completely repeated pharmacokinetic study of teprenone capsules in healthy subjects under fasting conditions and under single-center, open-label, randomized, single-dose, two-period, double-crossover fed conditions
主要目的
比较空腹和餐后给药条件下,华润双鹤利民药业(济南)有限公司生产的替普瑞酮胶囊(规格:50mg)与卫材(中国)药业有限公司生产的替普瑞酮胶囊(规格:50mg,商品名:施维舒®)在健康成年人群中吸收程度和速度的差异,同时验证分析方法、试验流程、采血点和试验设计的合理性,为正式试验设计提供依据。
次要目的
评价空腹和餐后给药条件下,华润双鹤利民药业(济南)有限公司生产的替普瑞酮胶囊(规格:50mg)与卫材(中国)药业有限公司生产的替普瑞酮胶囊(规格:50mg,商品名:施维舒®)在健康成年人群中的安全性。
[Translation] Main purpose
To compare the differences in absorption degree and speed of Teprenone Capsules (Specification: 50mg) produced by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and Teprenone Capsules (Specification: 50mg, Trade Name: Servier®) produced by Eisai (China) Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to verify the rationality of analytical methods, experimental procedures, blood collection points and experimental design, so as to provide a basis for formal experimental design.
Secondary purpose
To evaluate the safety of Teprenone Capsules (Specification: 50mg) produced by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and Teprenone Capsules (Specification: 50mg, Trade Name: Servier®) produced by Eisai (China) Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions.