[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover, postprandial bioequivalence study of faropenem sodium granules in Chinese healthy subjects
主要研究目的
本试验以北京民康百草医药科技有限公司持证的小儿法罗培南钠颗粒,规格:0.05g(以C12H15NO5S计)为受试制剂,以Maruho Co.,Ltd.(玛路弘株式会社)持证的小儿法罗培南钠颗粒(商品名:菲若姆),规格:0.05g(以C12H15NO5S计)为参比制剂,评估受试制剂和参比制剂在餐后条件下的生物等效性。
次要研究目的
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main study purpose
This study uses the certified pediatric faropenem sodium granules of Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd., specification: 0.05g (calculated as C12H15NO5S) as the test preparation, and the certified pediatric faropenem sodium granules (trade name: Feromu) of Maruho Co., Ltd., specification: 0.05g (calculated as C12H15NO5S) as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under postprandial conditions.
Secondary study purpose
Observe the safety of the test preparation and the reference preparation in healthy subjects.