[Translation] A randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-period, double-crossover bioequivalence study of oseltamivir phosphate dry syrup in healthy adult Chinese subjects
主要目的:考察单次口服75mg(空腹/餐后)受试制剂磷酸奥司他韦干糖浆(规格:3% (30g),博瑞制药(苏州)有限公司生产)与参比制剂磷酸奥司他韦干糖浆(商品名:TAMIFLU®,规格:3% (30g),中外製薬株式会社生产)在中国成年健康受试者体内的药代动力学特征,评价空腹与餐后状态分别口服两种制剂的生物等效性。
次要目的:评价受试制剂和参比制剂单次口服75mg(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Main purpose: To investigate the test preparation oseltamivir phosphate dry syrup (specification: 3% (30g), produced by Borui Pharmaceutical (Suzhou) Co., Ltd.) and the reference preparation oseltamivir phosphate, 75 mg per oral dose (fasting/after meals) The pharmacokinetic characteristics of Tasvir dry syrup (trade name: TAMIFLU®, specification: 3% (30g), produced by Chugai Separation Co., Ltd.) in Chinese adult healthy subjects were evaluated after oral administration in fasting and postprandial states. Bioequivalence of the preparations.
Secondary purpose: To evaluate the safety of a single oral dose of 75 mg (fasting/after meals) of the test preparation and reference preparation in Chinese adult healthy subjects.