[Translation] A single-dose, randomized, open-label, two-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of amoxicillin-clavulanate potassium tablets (amoxicillin 0.875 g and clavulanic acid 0.125 g, oral tablets) and Augmentin® (amoxicillin 0.875 g and clavulanic acid 0.125 g, oral tablets) in healthy male and female subjects under fasting conditions
主要研究目的
在健康男性和女性受试者中于空腹情况下评价阿莫西林克拉维酸钾片和 Augmentin®的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。
次要研究目的
评估受试制剂阿莫西林克拉维酸钾片和参比制剂 Augmentin®在健康受试者中的安全性。
[Translation] Primary study objective
To evaluate the absorption rate and extent of amoxicillin-clavulanate potassium tablets and Augmentin® in healthy male and female subjects under fasting conditions, and to evaluate whether the two preparations are bioequivalent.
Secondary study objective
To evaluate the safety of the test preparation amoxicillin-clavulanate potassium tablets and the reference preparation Augmentin® in healthy subjects.