NCT02576366已完成4 期
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in tacrolimus area under the curve
研究概览
简要总结
Single center, open label crossover study with 2 treatment phases in healthy volunteers.
The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years
- •Written informed consent
排除标准
- •Medical comorbidities
- •Use of concomitant medication
研究组 & 干预措施
Voriconazole
Experimental
Four hundred mg of voriconazole (2 tablets of 200 mg Vfend; Pfizer, Karlsruhe, Germany) will be administered twice daily on day 2. Two hundred mg of voriconazole (1 tablet of 200 mg Vfend) will be administered twice daily on days 3, 4, 5 and 6.
干预措施: Voriconazole (Drug)
Rifampin
Experimental
Six hundred mg of rifampicin (2 tablets of 300mg Rifadine; Sanofi, Belgium) will be administered once daily on days 7 through 13.
干预措施: Rifampin (Drug)
结局指标
主要结局
Change in tacrolimus area under the curve
时间窗: 2 weeks
assessed twice: once after each treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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