DRKS00012830已完成1 期
Effect of food on the pharmacokinetics ofonce-daily prolonged-release tacrolimus
niversitätsklinikum Heidelberg0 个研究点目标入组 37 人开始时间: 2017年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •Male or female Caucasian.
- •Age 18 to < 65 years.
- •BMI 18-30 kg/m2 and body weight >= 40 kg.
- •Good state of health (physically and mentally) as determined by medical assessment consisting of a medical history, physical examination, an ECG, and a laboratory evaluation that all show no clinically relevant abnormalities.
- •Known CYP3A5 genotype or participation in genotyping study.
- •No clinically relevant findings in any of the investigations of the SCR visit.
- •Agreement to abstain from St. John’s wort (Hypericum perforatum L.) during the time of the trial.
- •Agreement to follow specified dietary requirements (e.g. some citrus products, especially grapefruit, are not allowed).
- •Agreement to follow specified, highly effective contraceptive measures.
- •Able to communicate well with the investigator, to understand and comply with the requirements of the trial.
- •Voluntarily signed informed consent after full explanation of the trial to the participant.
排除标准
- •Intake of a substance known to induce or inhibit drug metabolizing enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or two weeks, whatever is longer (except oral contraceptives or levothyroxine).
- •Any physical disorder that could interfere with the participant’s safety during the clinical trial or with the trial objectives.
- •Any acute or chronic illness or clinically relevant finding in the pre-trial examination known or expected to modify absorption, distribution, metabolism, or excretion of the drug under investigation.
- •QTcF > 440 ms (males) or > 460 ms (females).
- •Regular smoking.
- •Excessive alcohol drinking (more than approximately 20 g/d alcohol).
- •Any participation in an interventional clinical trial within the last 4 weeks before inclusion.
- •Blood donation within 4 weeks (males) or 8 weeks (females) before the first trial day (refers to whole blood or red blood cell donation; plasma and/or platelet donation are considered acceptable).
- •Pregnancy or lactation.
- •Known intolerance to tacrolimus, midazolam, or further ingredients.
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