[Translation] Bioequivalence trial of pediatric faropenem sodium granules in Chinese healthy subjects under randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover, fasting and postprandial administration conditions
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空腹或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] This test uses pediatric faropenem sodium granules, specification: 0.05g (calculated as C12H15NO5S), licensed by Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. as the test preparation, and licensed by Maruho Co., Ltd. Pediatric faropenem sodium granules (trade name: Pherome), specification: 0.05g (calculated as C12H15NO5S), are used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting or postprandial conditions. Secondary research purpose: To observe the safety of test preparation and reference preparation in healthy subjects.