EUCTR2006-005249-13-DE进行中（未招募）不适用
Influence of the OATP1B1 genotype on the hepatic uptake of Primovist® in healthy volunteers and in patients with liver disease
Department of Clinical Pharmacology, University of Greifswald0 个研究点开始时间: 2007年1月25日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Inclusion criteria – healthy volunteers
- •*age:18 - 45 years
- •*sex:male and female
- •*ethnic origin:white
- •*body weight:? 19 kg/m² and ? 27 kg/m²
- •*good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
- •*written informed consent
- •Inclusion criteria – patients
- •*age:18 - 65 years
- •*sex:male and female
- •*ethnic origin:white
- •*any liver disease (e.g. primary liver tumor, metastatic liver disease, liver cirrhosis, steatosis hepatis) which is subjected to MRI diagnostics
- •*written 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria – healthy volunteers
- •weight less than 45 kg
- •claustrophobia
- •cardiac pacemakers, metallic implants or metal-containing tatoos
- •history of allergic reactions
- •known hypersensitivity to the study medication or to their adjuvants
- •existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics
- •existing hepatic and renal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics
- •existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics
- •acute or chronic diseases which could affect drug metabolism or elimination
- •history of any serious psychological disorder
- •drug or alcohol dependence
- •positive drug or alcohol screening
- •smokers of 10 or more cigarettes per day
- •positive anti-HIV-test, HBs-Ag-test or anti-HCV-test
- •volunteers who are on a diet which could affect the pharmacokinetics of the drug
- •heavy tea or coffee drinkers (more than 1L per day)
- •lactation and pregnancy test positive or not performed
- •volunteers suspected or known not to follow instructions
- •volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •volunteers liable to orthostatic dysregulation, fainting, or blackouts
- •participation in a clinical trial during the last 3 months prior to the start of the study
- •less than 14 days after last acute disease
- •any systemically available medication within 4 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites (except oral contraceptives)
- •repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin)
- •intake of grapefruit containing food or beverages within 7 days prior to administration
- •5.4Exclusion criteria – patients
- •weight less than 45 kg
- •claustrophobia
- •cardiac pacemakers, metallic implants or metal-containing tatoos
- •history of allergic reactions
- •known hypersensitivity to the study medication or to their adjuvants
- •acute bleedings within the last two weeks, elevated risk of acute bleedings (ulcer, oesophageal varicosis, regular intake of coumarines) or subnormal haemoglobin value
- •patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •patients liable to orthostatic dysregulation, fainting, or blackouts
- •lactation and pregnancy test positive or not performed
- •repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin)
- •intake of grapefruit containing food or beverages within 7 days prior to administration
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