NCT01932268已完成2 期
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration
研究概览
简要总结
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from 18yrs to 80yrs , man and women
- •the patient who are taking rifampicine over 2weeks
- •the patient sign on the concent form
排除标准
- •the patient have experience to take medication that have an effect on renal function
- •the patient have hypersensitivity to colchicine
- •At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40 beats/min or > 90 beats/min
- •uncontrolled hypertension
- •serum albumin < 3.5, > 5 g/dL
- •acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
- •the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
- •the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
- •the patient who had taken part in the other study within 3months
- •the patient who had gotten blood transfusion
- •pregnant, breast feeding
研究组 & 干预措施
Rifampicin
Experimental
experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin
干预措施: Rifampicin (Drug)
结局指标
主要结局
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration
时间窗: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration
次要结局
未报告次要终点
研究者
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