[Translation] To evaluate the effects of the test formulation amoxicillin and clavulanate potassium dry suspension and the reference formulation amoxicillin and clavulanate potassium dry suspension in healthy adult subjects in the fasting/postprandial state in a single-center, open-label, Randomized, single-dose, four-cycle, two-sequence, repeated crossover bioequivalence study
1.主要研究目的:
以鲁南贝特制药有限公司的阿莫西林克拉维酸钾干混悬剂为受试制剂,GlaxoSmithKline /SmithKline Beecham 持证的阿莫西林克拉维酸钾干混悬剂(Augmentin Duo®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药吸收速度和程度的差异,评价两制剂是否生物等效。
2.次要研究目的:
研究受试制剂阿莫西林克拉维酸钾干混悬剂(400/57mg)和参比制剂阿莫西林克拉维酸钾干混悬剂(Augmentin Duo®,400/57mg)在健康受试者中的安全性。
[Translation] 1. Main research purpose:
The amoxicillin and clavulanate potassium dry suspension of Lunanbeite Pharmaceutical Co., Ltd. was used as the test preparation, and the amoxicillin and clavulanate potassium dry suspension (Augmentin Duo®) certified by GlaxoSmithKline/SmithKline Beecham was used as the reference Compare the preparations and examine the difference in absorption rate and degree of single administration between the two preparations under fasting and postprandial conditions to evaluate whether the two preparations are bioequivalent.
2. Secondary research purpose:
Studying the test formulation Amoxicillin and Clavulanate Potassium Dry Suspension (400/57mg) and the reference formulation Amoxicillin and Clavulanate Potassium Dry Suspension (Augmentin Duo®, 400/57mg) in healthy subjects security.