/ RecruitingNot Applicable [Translation] Bioequivalence study of adenosylcobalamin tablets in humans
主要研究目的:以持证商为Eisai Co.,Ltd/エーザイ株式会社的腺苷钴胺胶囊(商品名:Hycobal,规格:0.5mg)为参比制剂,以福建古田药业有限公司提供的腺苷钴胺片(规格:0.25mg)为受试制剂,采用随机、开放、单剂量、两周期双交叉设计,比较两制剂在中国健康受试者中空腹和餐后状态下的药代动力学,并评估生物等效性。
次要研究目的:评价口服受试制剂腺苷钴胺片(规格:0.25mg)和参比制剂腺苷钴胺胶囊(商品名:Hycobal、规格:0.5mg)在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the adenosine cobalamin capsule (trade name: Hycobal, specification: 0.5 mg) of Eisai Co., Ltd. as the reference preparation and the adenosine cobalamin tablet (specification: 0.25 mg) provided by Fujian Gutian Pharmaceutical Co., Ltd. as the test preparation. A randomized, open, single-dose, two-period double crossover design was used to compare the pharmacokinetics of the two preparations in the fasting and postprandial states in healthy Chinese subjects and evaluate the bioequivalence.
Secondary purpose of the study: To evaluate the safety of the oral test preparation adenosine cobalamin tablet (specification: 0.25 mg) and the reference preparation adenosine cobalamin capsule (trade name: Hycobal, specification: 0.5 mg) in healthy Chinese subjects.
100 Clinical Results associated with Fujian Gutian Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Fujian Gutian Pharmaceutical Co., Ltd.
100 Deals associated with Fujian Gutian Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Fujian Gutian Pharmaceutical Co., Ltd.