[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of oseltamivir phosphate dry suspension in healthy subjects after fasting or after meals
主要目的:研究空腹和餐后状态下单次口服受试制剂磷酸奥司他韦干混悬剂(规格:6mg/ml,江西药都仁和制药有限公司持证生产)与参比制剂磷酸奥司他韦干混悬剂(TAMIFLU®,规格:6mg/ml, Roche Registration GmbH持证,Roche Pharma AG生产)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要目的:空腹和餐后状态下,研究单次口服受试制剂磷酸奥司他韦干混悬剂和参比制剂磷酸奥司他韦干混悬剂(TAMIFLU®)在健康成年受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of a single oral dose of the test preparation oseltamivir phosphate dry suspension (specification: 6 mg/ml, licensed production by Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd.) and the reference preparation oseltamivir phosphate dry suspension (TAMIFLU®, specification: 6 mg/ml, licensed by Roche Registration GmbH, produced by Roche Pharma AG) in healthy adult subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations in fasting and fed conditions.
Secondary objective: To study the safety of a single oral dose of the test preparation oseltamivir phosphate dry suspension and the reference preparation oseltamivir phosphate dry suspension (TAMIFLU®) in healthy adult subjects under fasting and fed conditions.