/ Not yet recruitingNot Applicable 小儿法罗培南钠颗粒在健康受试者中随机、开放、单剂量、两制剂、两周期、交叉设计空腹及餐后状态下生物等效性试验。
[Translation] A randomized, open-label, single-dose, two-formulation, two-period, crossover-design bioequivalence study of faropenem sodium granules in children in healthy subjects under fasting and fed conditions.
主要研究目的:健康受试者空腹及餐后口服单剂量小儿法罗培南钠颗粒后,观察法罗培南钠在体内动力学过程,估算相应的药代动力学参数,进行生物等效性评价。
次要研究目的:观察受试制剂小儿法罗培南钠颗粒和参比制剂小儿法罗培南钠颗粒(菲若姆)在健康受试者中的安全性。
[Translation] The main purpose of the study: After a single dose of pediatric faropenem sodium granules was taken orally on an empty stomach or after meals, the in vivo kinetics of faropenem sodium was observed, the corresponding pharmacokinetic parameters were estimated, and bioequivalence evaluation was performed.
Secondary purpose of the study: To observe the safety of the test preparation pediatric faropenem sodium granules and the reference preparation pediatric faropenem sodium granules (Firom) in healthy subjects.
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