ENALAPRIL AND CARVEDILOL WITH INHIBITION OF TRANSPORTERS BY FAMOTIDINE

法莫替丁抑制转运蛋白的依那普利和卡维地洛

• 批准号: 7716916
• 负责人: JO ELLEN RODGERS
• 金额: $ 0.09万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716916
• 关键词: Adult; Area; Blood; Chronic; Class; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Daily; Drug Kinetics; Drug usage; Enalapril; Enalaprilat; Ethnic Origin; Famotidine; Female; Funding; Grant; Heart; Heart failure; Hour; Institution; Label; Methods; New York; Participant; Patients; Plasma; Procedures; Purpose; Randomized; Recruitment Activity; Renal clearance function; Research; Research Personnel; Resources; Sampling; Source; Time; United States National Institutes of Health; Urine; carvedilol; day; enantiomer; male; volunteer

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. Purpose: This clinical study will evaluate the effect of famotidine on the plasma concentrations and renal clearance of enalapril and carvedilol, two drugs used in the treatment of chronic heart failure (HF). Participants: Patients with stable chronic HF (New York Heart Association (NYHA) class III), who currently are taking enalapril and carvedilol as part of their HF treatment will be recruited to participate in this study. Procedures (methods): This will be an open-labeled, randomized, crossover study in male and female adult volunteers of any ethnicity with HF. Blood and urine samples will be collected for 12 hours and analyzed for enalapril/enalaprilat and carvedilol (R and S enantiomers) without famotidine administration (control) and after administration of 20 mg famotidine twice daily for three days. Changes in pharmacokinetic parameters, particularly area under the concentration versus time curve (AUC) and renal clearance (CLR), will be evaluated.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 目的：本临床研究将评估法莫替丁对依那普利和卡维地洛这两种药物的血浆浓度和肾清除率的影响。 治疗慢性心力衰竭（HF）。 参与者：目前正在服用依那普利和卡维地洛作为心力衰竭治疗一部分的稳定慢性心力衰竭患者（纽约心脏协会 (NYHA) III 级）将被招募参加本研究。 程序（方法）：这将是一项开放标签、随机、交叉研究，对象为任何种族的患有心力衰竭的男性和女性成年志愿者。将在未给予法莫替丁（对照）和每天两次连续三天给予 20 mg 法莫替丁后收集 12 小时的血液和尿液样本，并分析依那普利/依那普利拉和卡维地洛（R 和 S 对映体）。将评估药代动力学参数的变化，特别是浓度与时间曲线下的面积（AUC）和肾清除率（CLR）。