DRKS00023556已完成1 期
Assessment of the effect of drug formulation on the extent of the pharmacokinetic interaction between St. John's Wort and tacrolimus - TacroSJW
niversität Heidelberg, Medizinische Fakultät0 个研究点目标入组 20 人开始时间: 2020年11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
- 20
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
- •BMI 18-30 kg/m² and body weight = 40 kg.
- •Participation in a genotyping study to determine CYP3A5 genotype.
- •Willing to use specified methods of contraception.
- •Agreement to follow specified dietary reqirements (e.g. grapefruit is not allowed).
排除标准
- •Clinically significant or relevant abnormalities in the medical history, physical examination, and laboratory evaluation as assessed by the investigator.
- •Any medical disorder that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMP or trial interventions.
- •Clinically relevant ongoing or clinically relevant history of physical or psychiatric illness as judged by the investigator.
- •Pregnancy or breast feeding.
- •Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of tacrolimus.
- •Any known history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies.
- •Any known allergies to the trial drugs, to other macrolides, or further ingredients of the administered IMPs.
- •Known light hypersensitivity of the skin.
- •Clinically relevant findings in screening investigations.
- •A positive result in the drug screening test at screening.
- •Use of any medication (prescription medication, non-prescription medication including multivitamin or herbal preparations) with active ingredients (except hormonal contraception, iodine, and thyroid hormones), within a period of less than 5 times the respective elimination half-time with regard to the expected date of the first dose of IMP.
- •Any intake of substances known to induce relevant metabolizing enzymes or drug transporters within a period of less than 14 days with regard to the expected date of the first dose of IMP.
- •Expected noncompliance to refrain from alcohol 24 hours before the pharmacokinetic days, or pathological alcohol consumption.
- •Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
- •QTcF > 440 ms (males) or > 460 ms (females).
- •Regular smoking.
研究者
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