[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of oseltamivir phosphate dry suspension in healthy adult Chinese subjects
主要研究目的:
考察单次单剂量口服75 mg(空腹/餐后)受试制剂磷酸奥司他韦干混悬剂【规格:0.36 g(按C16H28N2O4计),河北华晨药业集团有限公司生产】与参比制剂磷酸奥司他韦干混悬剂【商品名:Tamiflu®,规格:6 mg/mL(按C16H28N2O4计)(按C16H28N2O4计),HOFFMANN LA ROCHE INC持证,F.Hoffmann-La Roche Ltd生产】,在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:
评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of a single oral dose of 75 mg (fasting/postprandial) of the test formulation oseltamivir phosphate dry suspension [Specification: 0.36 g (calculated as C16H28N2O4), produced by Hebei Huachen Pharmaceutical Group Co., Ltd.] and the reference formulation oseltamivir phosphate dry suspension [trade name: Tamiflu®, specification: 6 mg/mL (calculated as C16H28N2O4) (calculated as C16H28N2O4), licensed by HOFFMANN LA ROCHE INC, produced by F.Hoffmann-La Roche Ltd] in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two formulations, and evaluate the bioequivalence of the two formulations.
Secondary study objectives:
To evaluate the safety of a single oral dose of the test formulation and the reference formulation on an empty stomach/postprandial basis in healthy Chinese adult subjects.