[Translation] A randomized, open-label, single-dose, two-formulation, three-sequence, three-period, partially repeated, crossover, fasting and fed bioequivalence study of probucol tablets in healthy subjects
主要目的:在中国健康受试者中评价山西华夏泰康医药集团有限公司委托浙江普利药业有限公司生产的普罗布考片(受试制剂,250mg)与日本上市的普罗布考片(参比制剂,Lorelco®,250mg,持证商:大塚制药株式会社)单次给药条件下的人体生物等效性。
次要目的:观察普罗布考片受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: To evaluate in Chinese healthy subjects the probucol tablets (test preparation, 250 mg) produced by Zhejiang Puli Pharmaceutical Co., Ltd. commissioned by Shanxi Huaxia Taikang Pharmaceutical Group Co., Ltd. and the probucol tablets marketed in Japan (reference Preparation, Lorelco®, 250mg, Licensee: Otsuka Pharmaceutical Co., Ltd.) Human bioequivalence under single-dose conditions.
Secondary purpose: To observe the safety of the test preparation and reference preparation of Probucol Tablets in Chinese healthy subjects.