Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve (AUC) of Tacrolimus and Mycophenolate mofetil
研究概览
简要总结
Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil, therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction between two drugs is still not well understood. Therefore, an open-label, three period, single dose trial is planned to investigate the drug interaction between tacrolimus and mycophenolate mofetil.
详细描述
Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil 1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg and tacrolimus 5mg. All subjects have one week of washing period between single dose administration. Blood samples are drawn up to 72 hours after drug administration. Single nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are also investigated. Drug interaction is going to be assessed through the ratio of area under the concentration curve of one drug in the presence or absence of another drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male adult with age of 19-45
- •Weight difference between ideal and actual body weight is less than 20%
- •Previous healthy with no known disease
- •Considered normal on physical exam, clinical laboratory tests(complete blood count, electrolyte, renal and hepatic function) and electrocardiogram
- •Never been heavy-drinker within one month prior to trial initiation and able to abstain from alcohol during trial
排除标准
- •Ever smoked within one year prior to trial initiation
- •Took other drugs (including herbal medicine) within one month prior to trial initiation
- •Alcohol or drug abuser
- •Participated another clinical trial within three months
- •Considered inadequate under investigator's discretion
研究组 & 干预措施
Tacrolimus and Mycophenolate mofetil
Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.
干预措施: Tacrolimus (Drug)
Tacrolimus and Mycophenolate mofetil
Tacrolimus 5mg single dose, Mycophenolate 1,000mg single dose, Tacrolimus 5mg and Mycophenolate 1,000mg single dose.
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
Area under the concentration versus time curve (AUC) of Tacrolimus and Mycophenolate mofetil
时间窗: 0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose
次要结局
- Adverse Drug Reaction(through study completion, an average of 1 month)
- Peak Concentration of Tacrolimus and Mycophenolate mofetil(0, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose)
研究者
Yon Su Kim
Principal Investigator
Seoul National University Hospital