[Translation] To evaluate the single-center, randomized, open-label, single-dose administration of the test preparation carbosulfonate sodium tablets (specification: 10 mg) and the reference preparation (Adona®, specification: 10 mg) in healthy adult subjects under fasting and postprandial states. Drug, two-period, double-crossover bioequivalence study
主要目的:以江苏吴中医药集团有限公司苏州制药厂的卡络磺钠片为受试制剂,以ニプロESファーマ株式会社的卡络磺钠片为参比制剂,通过单中心、随机、开放、单次给药、两周期、双交叉设计来评价两种制剂空腹及餐后状态下的人体生物等效性。
次要目的:观察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: Taking the Sodium Carbosulfate Tablets of Suzhou Pharmaceutical Factory of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. as the test preparation, and the Sodium Carbosulfonate Tablets of Nipro ES Pharma Co., Ltd. as the reference preparation, through a single center, random, open, Single administration, two periods, and double-crossover design were used to evaluate the human bioequivalence of the two preparations in the fasting and fed states.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.