[Translation] A randomized, open-label, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of doxofylline tablets in Chinese healthy subjects under fasting and fed administration conditions.
主要目的:以药代动力学参数为终点指标,比较空腹和高脂餐后给药条件下,合肥合源药业有限公司生产的多索茶碱片与ABC FARMACEUTICI S.P.A.为持证商的多索茶碱片(商品名:ANSIMAR®,规格:0.4g)在健康成年人群中吸收程度和速度的差异,对两制剂的生物等效性进行评价。
次要目的:评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂多索茶碱片和参比制剂多索茶碱片的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and rate between the doxofylline tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and the doxofylline tablets (trade name: ANSIMAR®, specification: 0.4g) licensed by ABC FARMACEUTICI S.P.A. in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of oral administration of the test preparation doxofylline tablets and the reference preparation doxofylline tablets in healthy subjects under fasting and high-fat meal administration conditions.