[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, repeated crossover controlled study was conducted to evaluate the bioequivalence of doxofylline granules in Chinese healthy subjects after a single oral dose in the fasting and fed state.
以浙江恒研医药科技有限公司提供的多索茶碱颗粒(规格:0.2g)为受试制剂;并以ABC FARMACEUTICI S.P.A.持证的多索茶碱颗粒(商品名:ANSIMAR®,规格:0.2g)为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] The doxofylline granules (specification: 0.2g) provided by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd. were used as the test preparation, and the doxofylline granules (trade name: ANSIMAR®, specification: 0.2g) certified by ABC FARMACEUTICI S.P.A. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.