Evaluation of the pharmacokinetics and food intake effect of generic sofosbuvir in healthy Chinese subjects
作者: Xin LiYujie LiuBing XuLihua LiuYuan LiPing ZhangYiya Wang
刊名: Int. Journal of Clinical Pharmacology and Therapeutics, 2020, Vol.58 (4), pp.230-241
来源数据库: Dustri-Verlag Dr. Karl Feistle GmbH & Co. KG
DOI: 10.5414/CP203649
原始语种摘要: Objective: Sofosbuvir is an NS5B nucleotide inhibitor that was approved for hepatitis C treatment. Generic sofosbuvir has been produced to improve the affordability. The present study investigated the pharmacokinetics (PK) and safety of generic sofosbuvir as well as the effect of food intake on its PK parameters in healthy Chinese subjects. Materials and methods: This open-label, randomized, multiple-dose, dose-escalating, and food effect trial enrolled 12 healthy Chinese subjects. The subjects received a single oral dose of 400 mg of generic sofosbuvir in fasted state or after a high-fat meal, or 800 mg in fasted state, in a three-way crossover design, and then all subjects were administered with 400 mg daily for 8 days. The PK parameters for sofosbuvir and its metabolites were...
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  • healthy 健康的
  • effect 效应
  • metabolite 蚀变粗玻岩
  • intake 收气
  • generic 属的
  • dosing 配量
  • increased 增加
  • plasma 深绿玉髓
  • altering 修改
  • absorbed 被吸收的