[Translation] Bioequivalence of the two preparations of Albexostat Tosylate Tablets before and after the change in Chinese healthy subjects in a single-center, randomized, open-label, two-preparation, fasting, single-dose, two-cycle, two-sequence, crossover design sex research
考察空腹条件下健康受试者单次口服变更后的甲苯磺酸艾贝司他片(研究药物:T1)与变更前的甲苯磺酸艾贝司他片(对照药物:T2)的相关药代动力学参数,对比两制剂在健康人体内的吸收速度及吸收程度,评价变更前后两种制剂(T1和T2)的生物等效性,同时评价两制剂在健康受试者中的安全性。
[Translation] To investigate the pharmacokinetics of healthy subjects taking a single oral administration of the changed Ibexostat Tosylate Tablets (study drug: T1) and the pre-changed Ibexostat Tosylate Tablets (control drug: T2) under fasting conditions. Kinetic parameters, compare the absorption speed and degree of absorption of the two preparations in healthy humans, evaluate the bioequivalence of the two preparations (T1 and T2) before and after the change, and evaluate the safety of the two preparations in healthy subjects.