Division of Infectious Diseases, Department of Medicine, Washington University in St. Louis, St Louis, Missouri, USA.
Mayne Pharma, Medical Affairs, Raleigh, North Carolina, USA.
Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0013421. doi: 10.1128/AAC.00134-21.
Conventional itraconazole (C-ITZ) suffers from absorption variability. SUBA-itraconazole (S-ITZ) is more bioavailable than C-ITZ at steady state in a fed condition, but there are no data comparing the two under a fasted state. An open-label, single-dose, randomized, bioequivalence study was performed comparing S-ITZ to C-ITZ capsules under fasted and fed conditions in healthy adults measuring itraconazole and hydroxyitraconazole plasma levels. This study demonstrated less variability of S-ITZ compared to C-ITZ capsules under fasted conditions.
传统的伊曲康唑（C-ITZ）吸收存在变异性。在进食状态下，与 C-ITZ 相比，SUBA-itraconazole（S-ITZ）在稳态时具有更好的生物利用度，但在空腹状态下尚无比较两种药物的相关数据。一项开放标签、单剂量、随机、生物等效性研究在健康成年人中进行，比较了空腹和进食条件下 S-ITZ 胶囊与 C-ITZ 胶囊的情况，检测伊曲康唑和羟基伊曲康唑的血浆水平。本研究表明，与 C-ITZ 胶囊相比，S-ITZ 在空腹状态下具有更小的变异性。
