[Translation] A randomized, open-label, two-cycle, two-sequence, crossover human bioequivalence study of single-dose oral amoxicillin capsules in healthy volunteers
(1)通过阿莫西林胶囊空腹和餐后给药的生物等效性研究,评价四川峨嵋山药业有限公司生产的阿莫西林胶囊与Beecham Group plc的阿莫西林胶囊的生物等效性,为四川峨嵋山药业有限公司生产的阿莫西林胶囊与 Beecham Group plc的阿莫西林胶囊临床疗效的一致性提供证据。
(2)对阿莫西林胶囊的安全性进行评价。
[Translation] (1) To evaluate the bioequivalence of amoxicillin capsules produced by Sichuan Emeishan Pharmaceutical Co., Ltd. and Amoxicillin capsules of Beecham Group plc through the bioequivalence study of amoxicillin capsules administered on an empty stomach and after meals, To provide evidence for the consistency of the clinical efficacy of amoxicillin capsules produced by Sichuan Emeishan Pharmaceutical Co., Ltd. and Beecham Group plc's amoxicillin capsules.
(2) To evaluate the safety of amoxicillin capsules.