发明名称 COMPOSITION AND METHOD FOR ORAL DELIVERY OF ANDROGEN PRODRUGS
摘要 Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.
申请公布号 US2016361322(A1) 申请公布日期 2016.12.15
申请号 US201615183691 申请日期 2016.06.15
申请人 Lipocine Inc. 发明人 Patel Mahesh V.;Chidambaram Nachiappan;Nachaegari Satish K.
分类号 A61K31/568;A61K47/12;B65D1/02;A61K47/10;B65D25/20;A61J1/03;A61K9/00;A61K47/22 主分类号 A61K31/568
代理机构 代理人
主权项 1. A method for replacement therapy in a male for a condition associated with a deficiency or absence of endogenous testosterone, said method comprising: orally administering to a male having a condition associated with a deficiency or absence of endogenous testosterone, with a meal, a pharmaceutical composition comprising from about 50 mg to about 300 mg of testosterone undecanoate and a pharmaceutically acceptable carrier said pharmaceutical acceptable carrier being selected to provide bioequivalent amounts of serum testosterone, testosterone undecanoate, dihydrotestosterone, or dihydrotestosterone undecanoate levels to said male when administered with (1) meals containing standard fat as compared to low fat and high fat, (2) meals containing low fat as compared to high fat, or both (1) and (2).
地址 Salt Lake City UT US
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