Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under the curve, bioavailability, time of maximal concentration, elimination constant
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included.
- •Age: 18 - 65 years
- •Patient's informed consent
排除标准
- •Patients that use drugs that interact with tacrolimus
- •Patients that participate in other studies
- •Patients that are treated with tacrolimus
研究组 & 干预措施
Sublingual - Rectal - Oral
Administration order of rank: Sublingual - Rectal - Oral
干预措施: Tacrolimus (Drug)
Sublingual - Oral - Rectal
Administration order of rank: Sublingual - Oral - Rectal
干预措施: Tacrolimus (Drug)
Oral - Sublingual - Rectal
Administration order of rank: Oral - Sublingual - Rectal
干预措施: Tacrolimus (Drug)
Oral - Rectal - Sublingual
Administration order of rank: Oral - Rectal - Sublingual
干预措施: Tacrolimus (Drug)
Rectal - Sublingual - Oral
Administration order of rank: Rectal - Sublingual - Oral
干预措施: Tacrolimus (Drug)
Rectal - Oral - Sublingual
Administration order of rank: Rectal - Oral - Sublingual
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Area under the curve, bioavailability, time of maximal concentration, elimination constant
时间窗: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours
次要结局
未报告次要终点