[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, self-crossover controlled study to evaluate the bioequivalence of tranexamic acid tablets in Chinese healthy subjects after a single oral dose in the fasting and fed state
主要目的:以杭州志呈科技有限公司提供的氨甲环酸片为受试制剂,按生物等效性试验的有关规定,与DAIICHI SANKYO CO.,LTD.持证的氨甲环酸片(商品名:Transamin®/妥塞敏®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main purpose: To compare the absorption rate and extent of tranexamic acid tablets provided by Hangzhou Zhicheng Technology Co., Ltd. with those of tranexamic acid tablets (trade name: Transamin®/Tosamine®, reference preparation) certified by DAIICHI SANKYO CO., LTD. in healthy humans, and to investigate the bioequivalence of the two preparations in humans according to the relevant provisions of bioequivalence studies.