EFFECT OF CLARITHROMYCIN ON THE ORAL CLEARANCE OF BUSPIRONE IN PATIENTS WITH

克拉霉素对丁螺环酮口腔清除率的影响

• 批准号: 7717539
• 负责人: STEPHEN D HALL
• 金额: $ 0.01万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717539
• 关键词: Anti-Anxiety Agents; Buspirone; CYP3A4 gene; Cirrhosis; Clarithromycin; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Exhibits; Funding; Goals; Grant; Hepatic; Individual; Institution; Intestines; Label; Oral; Patients; Pharmaceutical Preparations; Randomized; Research; Research Personnel; Resources; Risk; Source; Transjugular intrahepatic portosystemic shunt procedure; United States National Institutes of Health; cytochrome P450 3A; enzyme activity; healthy volunteer; treatment duration

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 intestinal CYP3A activity is markedly diminished in cirrhotics with transjugular intrahepatic portasystemic shunts (TIPS). These patients are expected to be at risk for excessive pharmacological effects of drugs that are metabolized by Cytochrome P450 (CYP) 3A. Buspirone is a widely used anxiolytic medication that is highly dependent on CYP 3A enzyme activity for elimination. The oral clearance of buspirone is significantly reduced in individuals with cirrhosis due to decrease in hepatic CYP3A enzyme activity. The goal of the current study is to characterize the change in the pharmacokinetics of orally administered buspirone with 7 day treatment of clarithromycin by conducting an open label, randomized study of 12 cirrhotics with TIPS, 12 cirrhotics and 12 healthy volunteers. We will compare the extent of interaction as reflected in the ratio of buspirone AUC following clarithromycin dosing to the buspirone AUC before clarithromycin dosing in the three groups. We expect that healthy volunteers and cirrhotics without TIPS will exhibit

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。 肠内肠疾病中的肠内CYP3A活性显着降低，具有经舌的肝内Portasytystystenic分类（TIPS）。预计这些患者有可能因细胞色素P450（CYP）3A代谢的药物的药理作用过多。 Buspirone是一种广泛使用的抗焦虑药，高度依赖于CYP 3A酶活性以消除。由于肝CYP3A酶活性的降低，肝硬化个体的口服清除率显着降低。当前研究的目的是通过对克拉霉素进行7天治疗的口服给药的药代动力学的变化，通过进行开放的标签，随机研究12种带有技巧，12个cirrhotics和12名健康志愿者的肝硬化。我们将比较在克拉霉素给药与丁螺酮AUC之后反映的相互作用程度，然后在三组中克拉霉素给药之前。我们希望健康的志愿者和无技巧的志愿者将展示