NCT01034124已完成不适用
Mechanisms Underlying Drug-Diet Interactions
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years of age
- •Not taking medications known to modulate CYP2C9 and CYP3A activity
- •Able to understand the consent process
排除标准
- •Allergy to cranberry products, warfarin, vitamin K, or midazolam
- •Pregnant or breast-feeding women
- •Baseline INR >1.2
- •History of significant medical conditions that could increase risk
- •Concomitant medications known to modulate CYP2C9 and CYP3A activity
研究组 & 干预措施
Water
Placebo Comparator
干预措施: warfarin, vitamin K, midazolam (Drug)
Cranberry juice
Active Comparator
干预措施: warfarin, vitamin K, midazolam (Drug)
结局指标
主要结局
AUC
时间窗: 0-96 hr
次要结局
- Cmax(varies)
研究者
研究点 (1)
Loading locations...
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