[Translation] A single-dose, randomized, open-label, four-period, fully repeated crossover design bioequivalence study of doxofylline tablets in fed state in healthy subjects
主要研究目的:
研究餐后状态下单次口服受试制剂多索茶碱片(规格:400mg,杭州沐源生物医药科技有限公司)与参比制剂多索茶碱片(商品名:ANSIMAR®,规格:400mg,ABC FARMACEUTICI S.P.A.)在健康成年受试者体内的药代动力学,评价餐后状态下口服两种制剂的生物等效性。
次要研究目的:
评价健康受试者餐后单次口服受试制剂(T)多索茶碱片和参比制剂(R)多索茶碱片(商品名:ANSIMAR®)后的安全性。
[Translation] Main research purposes:
The test preparation doxofylline tablet (specification: 400mg, Hangzhou Muyuan Biomedical Technology Co., Ltd.) and the reference preparation doxofylline tablet (trade name: ANSIMAR®, specification: 400mg, Pharmacokinetics of ABC FARMACEUTICI S.P.A.) in healthy adult subjects, to evaluate the bioequivalence of two oral preparations in the fed state.
Secondary research purposes:
To evaluate the safety of healthy subjects after a single oral administration of the test preparation (T) doxofylline tablets and the reference preparation (R) doxofylline tablets (trade name: ANSIMAR®).