Prediction of Drug Interactions With CYP2C9 Substrates
Prediction of Potential Drug Interaction With CYP2C9 Substrate by Using Phenytoin Metabolic Ratio as a Marker of Its Activity in-Vivo.
CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic cytochrome P450 content and being second only to CYP3A4.
The proposed study will explore different possible drug interactions with CYP2C9 substrates by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait measurement. It is expected that the identification of drugs that might interact with CYP2C9 substrates will be used to rationalize future drug interaction studies designed to evaluate the actual magnitude of effect and its clinical implications. This approach should be particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic index (i.e. warfarin).
This study will consist of three study periods separated from each other by a two weeks washout period. In the course of the study the subjects will receive in a double blind, crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as identical looking tablets that will be prepared at the pharmacy of the Hadassah University Hospital and their order of administration will be randomized.On the day prior to, on day 6 of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin intake.
研究概览
研究类型
注册
阶段
- 不适用
联系人和位置
学习地点
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Jerusalem、以色列
- Hadassah Medical Organization
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age range 20-50
- Absence of significant disease states
Exclusion Criteria:
- Known hypersensitivity to one of the drugs used in the study
- Significant disease states
- Regular use of drugs (including birth control pills)
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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Phenytoin metabolic ratio prior to and following exposure to fluconazole, diclophenac and rifampicin.
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合作者和调查者
调查人员
- 首席研究员:Yoseph Caraco, MD、Hadassah Medical Organization
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 周围神经系统药物
- 核酸合成抑制剂
- 酶抑制剂
- 止痛药
- 感觉系统代理
- 抗炎药,非甾体
- 镇痛药,非麻醉药
- 抗炎药
- 抗风湿药
- 环氧合酶抑制剂
- 激素、激素替代品和激素拮抗剂
- 抗菌剂
- 膜转运调节剂
- 细胞色素 P-450 酶抑制剂
- 麻风剂
- 抗惊厥药
- 电压门控钠通道阻滞剂
- 钠通道阻滞剂
- 激素拮抗剂
- 细胞色素 P-450 CYP1A2 诱导剂
- 细胞色素 P-450 酶诱导剂
- 抗真菌剂
- 类固醇合成抑制剂
- 细胞色素 P-450 CYP3A 诱导剂
- 抗结核药
- 14-α 去甲基化酶抑制剂
- 抗生素,抗结核药
- 细胞色素 P-450 CYP2B6 诱导剂
- 细胞色素 P-450 CYP2C8 诱导剂
- 细胞色素 P-450 CYP2C19 诱导剂
- 细胞色素 P-450 CYP2C9 诱导剂
- 细胞色素 P-450 CYP2C9 抑制剂
- 细胞色素 P-450 CYP2C19 抑制剂
- 利福平
- 双氯芬酸
- 氟康唑
- 苯妥英钠
其他研究编号
- yc19555-HMO-CTIL
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氟康唑的临床试验
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University of MinnesotaNational Institute of General Medical Sciences (NIGMS)完全的