[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study of oseltamivir phosphate capsules in Chinese healthy volunteers under fasting and fed conditions
主要研究目的:本试验以江西大生医药科技有限公司的磷酸奥司他韦胶囊(规格:75mg)为受试制剂,以Roche Pharma (Schweiz) AG持证、Delpharm Milano S.r.l.生产的磷酸奥司他韦胶囊(商品名:达菲®/Tamiflu®,规格:75mg)为参比制剂,分别考察空腹和餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
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] Primary Study Objective: This trial used oseltamivir phosphate capsules (75 mg) manufactured by Jiangxi Dasheng Pharmaceutical Technology Co., Ltd. as the test formulation and oseltamivir phosphate capsules (75 mg, trade name: Tamiflu®) manufactured by Delpharm Milano S.r.l. under license from Roche Pharma (Schweiz) AG as the reference formulation. The pharmacokinetic parameters of the test and reference formulations were evaluated in healthy volunteers under both fasting and fed conditions to assess their bioequivalence.
Secondary Study Objective: To observe the safety of the test and reference formulations in healthy volunteers.