[Translation] A single-center, randomized, open-label, single-dose, two-dose, four-cycle, two-sequence crossover human bioequivalence study of adenosylmethionine butanedisulfonate enteric-coated tablets in healthy people
本试验旨在研究单次空腹和餐后口服浙江普洛康裕制药有限公司研制、生产的丁二磺酸腺苷蛋氨酸肠溶片(0.5 g)的药代动力学特征;以ABBOTT LABORATORIES (M) SDN. BHD生产的丁二磺酸腺苷蛋氨酸肠溶片(思美泰®,0.5 g)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性,并观察两制剂在健康受试者中的安全性。
[Translation] The purpose of this test is to study the pharmacokinetic characteristics of adenosylate methionine enteric-coated tablets (0.5 g) developed and produced by Zhejiang Prokangyu Pharmaceutical Co., Ltd. after a single fasting and postprandial oral administration; ABBOTT LABORATORIES (M) Adenosylmethionine butanedisulfonate enteric-coated tablets (Simeitai®, 0.5 g) produced by SDN. BHD was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared, and the pharmacokinetics of the two preparations were evaluated. Human bioequivalence was observed, and the safety of the two preparations in healthy subjects was observed.