[Translation] Bioequivalence study of amoxicillin granules (0.125g) in healthy subjects under open, randomized, two-cycle, two-sequence, self-crossover, fasting and postprandial states
主要目的为以珠海联邦制药股份有限公司中山分公司研制、生产的阿莫西林颗粒(0.125g/袋,按C16H19N3O5S 计0.125g)为受试制剂,LTLファーマ株式会社阿莫西林细粒剂(10%,以C16H19N3O5S计,100mg/1g/袋,商品名:Sawacillin ®)为参比制剂,研究受试制剂和参比制剂在健康受试者空腹及餐后条件下单剂量给药时两制剂的人体生物等效性。次要研究目的为观察健康受试者单次口服受试制剂和参比制剂的安全性。
[Translation] The main purpose is to use the amoxicillin granules (0.125g/bag, 0.125g in terms of C16H19N3O5S) developed and produced by Zhongshan Branch of Zhuhai United Laboratories Co., Ltd. as the test preparation, and the amoxicillin fine granules (10 %, based on C16H19N3O5S, 100mg/1g/bag, trade name: Sawacillin ®) as the reference preparation, the research test preparation and the reference preparation were administered in a single dose in healthy subjects under fasting and postprandial conditions. Human bioequivalence. The secondary study objective was to observe the safety of a single oral dose of the test preparation and the reference preparation in healthy subjects.