EUCTR2020-001655-41-FR进行中（未招募）1 期
P-glypoprotein inhibition effect on the pharmacokinetics of two tacrolimus formulations: prolonged and extended-release - DIPLOID
CHU de Rennes0 个研究点目标入组 28 人开始时间: 2020年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- adults (> 18 years)
- •- Non smokers
- •- Biological parameters within normal range (blood count, urea, creatinine, AST, ALT, GGT, bilirubine)
- •- BMI within 18 and 25
- •- Negative urinary and plasma pregnancy test
- •- Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •- participation to another study with incompatible procedure regarding the French law on research
- •- Treatment with a drug drug interaction with tacrolimus
- •- Cardiac rhythm at rest below 50 bpm
- •- Cardiac issue detected on electrocardiogram
- •- Cancer or history of cancer
- •- Chronic infection or history of chronic infection
- •- Diabetes or history of diabetes
- •- Hypertension or history of hypertension
- •- Pregnancy or lactation
- •- Deprived of liberty (curatorship, guardianship or incarcerate)
研究者
相似试验
进行中（未招募）
不适用
The effect of P-glycoprotein transport inhibition on brainmechanisms of sedation and cognitive impairment following antihistamines in healthy volunteersTo assess the effects of inhibition of the P-glycoproteine transporter (by verapamil 120 mg) on cetirizine 15 mg in healthy volunteers.EUCTR2010-023861-23-NLMaastricht University16
已完成
4 期
The effect of P-glycoprotein transport inhibition on brainmechanisms of sedation and cognitive impairment following antihistamines in healthy volunteers.cognitief functionerensedation / drowsinessNL-OMON36339niversiteit Maastricht16
已完成
不适用
The effect of inhibition of a transporter on sedation after antihistamine administration.Healthy subjects, sedation, antihistamines, P-glycoproteintransporter, fMRI, attention.Gezonde proefpersonen, vermoeidheid, antihistamines, P-glycoproteinetransporter, fMRI, aandacht.NL-OMON26369Maastricht University16
已完成
2 期
P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-releasePharmacokineticsNCT04489134Rennes University Hospital27
已完成
不适用
Role of P-glycoprotein inhibitor in children with interactable epilepsy [retrospectively registered]PACTR201110000335351yasmin galal30