[Translation] Single-center, postprandial, randomized, open-label, single-dose, two-preparation, two-cycle crossover human bioequivalence trial of oseltamivir phosphate capsules in Chinese healthy subjects
主要研究目的:以植恩生物技术股份有限公司生产的磷酸奥司他韦胶囊(75mg)为受试制剂(T),按有关生物等效性试验的规定,以 Delpharm Milano S.r.l.生产的磷酸奥司他韦胶囊(75mg)为参比制剂(R)进行生物等效性试验。
次要研究目的:观察受试制剂和参比制剂磷酸奥司他韦胶囊(75mg)在健康受试者中的安全性。
[Translation] Main research purpose: Oseltamivir phosphate capsules (75 mg) produced by Zion Biotechnology Co., Ltd. were used as the test preparation (T). According to the relevant bioequivalence test regulations, oseltamivir phosphate produced by Delpharm Milano S.r.l. Tasvir capsules (75 mg) are the reference preparation (R) for bioequivalence testing.
Secondary research purpose: To observe the safety of the test preparation and reference preparation oseltamivir phosphate capsules (75 mg) in healthy subjects.