[Translation] A single-center, randomized, open-label, two-dose, four-cycle, fully repeated human bioequivalence study of enteric-coated adenosylmethionine butanedisulfonate tablets in healthy subjects
主要研究目的:
考察健康受试者在空腹及餐后条件下,单次口服1片由北京金城泰尔制药有限公司生产的丁二磺酸腺苷蛋氨酸肠溶片(受试制剂T,规格:0.5g)与相同状态下单次口服1片由ABBOTT LABORATORIES (M) SDN. BHD持证的丁二磺酸腺苷蛋氨酸肠溶片(参比制剂R,商品名:思美泰®,规格:0.5g)的药动学特征,评价两制剂的生物等效性,为该受试制剂注册申请提供依据。
次要研究目的:
观察健康受试者在空腹及餐后条件下单次口服受试制剂丁二磺酸腺苷蛋氨酸肠溶片(规格:0.5g)或参比制剂丁二磺酸腺苷蛋氨酸肠溶片(商品名:思美泰®,规格:0.5g)在中国健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of a single oral tablet of 1 tablet of 5-adenosylmethionine disulfonate enteric-coated tablets (test preparation T, specification: 0.5g) produced by Beijing Jincheng Taier Pharmaceutical Co., Ltd. and a single oral tablet of 1 tablet of 5-adenosylmethionine disulfonate enteric-coated tablets (reference preparation R, trade name: Sumeta®, specification: 0.5g) certified by ABBOTT LABORATORIES (M) SDN. BHD under the same conditions, evaluate the bioequivalence of the two preparations, and provide a basis for the registration application of the test preparation.
Secondary study objectives:
To observe the safety of a single oral administration of the test preparation 5-adenosylmethionine disulfonate enteric-coated tablets (specification: 0.5g) or the reference preparation 5-adenosylmethionine disulfonate enteric-coated tablets (trade name: Sumeta®, specification: 0.5g) in healthy subjects in China under fasting and postprandial conditions.