A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Compare Cmax of methotrexate
研究概览
简要总结
To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 50, healthy male subjects (at screening)
- •Body weight between 50.0 kg - 90.0 kg, BMI between 18.0 - 30.0 kg/m2
- •Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
排除标准
- •Subject who has a past or present history of any diseases (eg. liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
- •Subject who had GI tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
- •Serum AST(SGOT), ALT(SGPT), total bilirubin >1.5 times upper limit of normal range, MDRD eGFR < 60mL/min/1.73m2, WBC count < 3,500 /uL, SBP < 90 mmHg or > 150 mmHg, DBP < 50 mmHg or >100 mmHg
- •Subject who had galactose intolerance, Lapplactase deficiency or glucose-galactose malabsorption
- •Subject who had received drugs inhibiting or inducing metabolic enzymes/transporters such as barbiturates, statins, digoxin in 3 months
- •Subject who had taken St.John's wort and food including grapefruit in 2 weeks
- •Smoking in 3 months
- •Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently
研究组 & 干预措施
Methotrexate
干预措施: Methotrexate Sodium (Drug)
Methotrexate + Rifampicin
Methotrexate + Rifampicin
干预措施: Methotrexate Sodium (Drug)
Methotrexate + Rifampicin
Methotrexate + Rifampicin
干预措施: Rifampicin Sodium (Drug)
Methotrexate + Febuxostat
Methotrexate + Febuxostat
干预措施: Methotrexate Sodium (Drug)
Methotrexate + Febuxostat
Methotrexate + Febuxostat
干预措施: Febuxostat Tablets (Drug)
Methotrexate + Rifampicin + Febuxostat
Methotrexate + Rifampicin + Febuxostat
干预措施: Methotrexate Sodium (Drug)
Methotrexate + Rifampicin + Febuxostat
Methotrexate + Rifampicin + Febuxostat
干预措施: Rifampicin Sodium (Drug)
Methotrexate + Rifampicin + Febuxostat
Methotrexate + Rifampicin + Febuxostat
干预措施: Febuxostat Tablets (Drug)
结局指标
主要结局
Compare Cmax of methotrexate
时间窗: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare the maximum concentration (Cmax), area under the plasma concentration-time curve to last measurable time point (AUClast) and area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate
Compare AUClast of methotrexate
时间窗: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare the area under the plasma concentration-time curve to from 0 to last measurable time point (AUClast) of methotrexate
Compare AUCinf of methotrexate
时间窗: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate
次要结局
- Compare Cmax of 7-hydroxy methotrexate(pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1))
- Compare AUClast of 7-hydroxy methotrexate(pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1))
- Compare AUCinf of 7-hydroxy methotrexate(pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1))
研究者
Jae Yong Chung, MD, PhD
Professor
Seoul National University Hospital