ENALAPRIL AND CARVEDILOL WITH INHIBITION OF TRANSPORTERS BY FAMOTIDINE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的：本临床研究将评价法莫替丁对依那普利和卡维地洛的血药浓度和肾清除量的影响。 慢性心力衰竭(心衰)的治疗。 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性慢性心力衰竭患者(纽约心脏协会(NYHA)III级)将被招募参加这项研究。 程序(方法)：这将是一项开放标记、随机、交叉研究，对象为任何种族的成年男性和女性心力衰竭志愿者。采集血样和尿样12小时，分析依那普利/依那普利拉和卡维地洛(R和S对映体)，不给法莫替丁(对照组)和给法莫替丁20 mg，每日2次，连续3天。将评估药物动力学参数的变化，特别是血药浓度-时间曲线(AUC)和肾清除(CLR)下的面积。

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.