NL-OMON36191已完成不适用
Pharmacokinetic study of rectal and sublingual administration of tacrolimus in healthy volunteers - Rectal and sublingual administration of tacrolimus
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •healthy male and female volunteers;
- •18-65 years old;
- •using adequate contraception (female volunteers of childbearing potential);
- •able to comply with the study protocol;
- •willing to give written informed consent.
排除标准
- •concomitant use of medication, grapefruit juice or St John*s worth;
- •smoking 10 or more cigarettes per day and not able or willing to retain from smoking on days of administration;
- •simultaneous participation in another clinical trial;
- •pregnancy or lactation (female volunteers);
- •abnormal liver biochemistry (>2x upper normal limit);
- •renal insufficiency (estimated creatinin clearance according to Cockroft-Gault < 70 mL/min);
- •blood pressure >160/100 mmHg, measured after at least 10 minurtes rest in semi-recumbant position;
- •prolonged QT interval, corrected for heart rate using the Bazett's formula;
- •active infection, as determined by clinical examination.
研究者
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