[Translation] A randomized, open-label, two-period, two-sequence, crossover bioequivalence study of amoxicillin capsules in healthy volunteers after fasting or postprandial administration
(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 Beecham Group plc through a bioequivalence study of amoxicillin capsules administered on an empty stomach and after a meal, and to provide evidence for the consistency of clinical efficacy between amoxicillin capsules produced by Sichuan Emeishan Pharmaceutical Co., Ltd. and Beecham Group plc.
(2) To evaluate the safety of amoxicillin capsules.