PHASE IIA, PILOT, PHARMACOKINETIC STUDY OF ORAL TESTOSTERONE ESTER FORMULATIO

口服睾酮酯制剂的 IIA 期试验药代动力学研究

• 批准号: 7952260
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 21.97万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952260
• 关键词: Adverse effects; Asia; Australia; Blood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Country; Dose; Drug Formulations; Drug Kinetics; Esters; Europe; Funding; Grant; Hormones; Human body; Injection of therapeutic agent; Institution; Intestines; Lipids; Liver; Marketing; Measures; Oral; Oral cavity; Pharmaceutical Preparations; Phase; Preparation; Research; Research Personnel; Resources; Source; Testosterone; Testosterone Enanthate; Time; United States; United States National Institutes of Health; absorption; male; men; oral form testosterone; standard of care

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to determine how two new oral formulations (medications to be taken by mouth) of male hormone Testosterone (also called T-esters) are metabolized by human body. This will be done by giving different doses of these T-esters to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remains in the blood at set time points. These new formulations contain male hormone testosterone in the form of Testosterone Enanthate (TE) or Testosterone Undecanoate (TU) combined with a lipid (fatty) compound. The lipid part of these medications makes absorption of the testosterone portion easier and more efficient by being largely absorbed in the intestine instead of first going to and being broken down by the liver. TE has been used as an injection for the treatment of hypogonadal men for over 50 years and is the standard of care in the United States. There is no oral preparation of TE available. Oral TU and recently TU injections have been approved in Europe, Asia, and Australia for male hormone treatment of hypogonadal men. The TI preparation under study is formulated differently from the TU marketed in other countries. It is anticipated that this new TU preparation may last longer. These esters, when injected or taken by mouth, are broken down to testosterone portion and the ester portion. The ester portion is metabolized without any action in the body (i.e. cause no side effects).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的目的是确定男性激素睾丸激素（也称为t-sterers）如何通过人体代谢，如何将两种新的口服配方（用口口相关）（也称为T植物）。这将通过将这些T仪的不同剂量的男性（男性缺乏雄性激素）提供给您来完成，并测量在设定的时间点中保留多少这些药物。 这些新配方包含雄性激素睾丸激素的形式，睾丸激素（TE）或睾丸激素异酯（TU）与脂质（脂肪）化合物相结合。 这些药物的脂质部分使睾丸激素部分吸收在很大程度上吸收在肠中，而不是首先被肝脏吸收并被肝脏分解。 TE已被用作治疗性降压男性的注射，已有50多年的历史，并且是美国的护理标准。没有口头准备TE。口服TU和最近的TU注射已在欧洲，亚洲和澳大利亚批准，用于雄性荷尔蒙男性的雄性激素治疗。所研究的TI制备与其他国家 /地区销售的TU进行了不同。预计这种新的TU制剂可能会持续更长的时间。 这些酯在口腔注射或摄取时，被分解为睾丸激素部分和酯部分。 酯部分被代谢没有任何作用（即不会引起副作用）。