[Translation] A single-dose, two-formulation, fasting/fed, randomized, open-label, two-period, crossover bioequivalence study of oseltamivir phosphate capsules in healthy subjects
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服磷酸奥司他韦胶囊(规格:75mg)后的体内药代动力学特征,评价受试制剂(T)与参比制剂(R)的生物等效性。
次要目的:评价单剂量口服磷酸奥司他韦胶囊(75mg)受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of a single oral dose of oseltamivir phosphate capsules (specification: 75 mg) in Chinese healthy subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the test formulation (T) and the reference formulation (R).
Secondary objective: To evaluate the safety of a single oral dose of oseltamivir phosphate capsules (75 mg) in healthy subjects.