EUCTR2009-010422-20-SE进行中（未招募）不适用
Evaluation of the imaging quality of CMC-001(manganese chloride tetrahydrate) in liver Magnetic Resonance Imaging (MRI) in healthy volunteers. A double-blind, randomized cross-over, dose-response study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1/ Provision of informed consent prior to conducting any study-related procedures.
- •2/ Healthy volunteer, female or male aged 18 years.
- •3/ Able and willing to co-operate.
- •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
- •1)A positive laboratory test result for hepatitis B or C or Human Immunodeficiency Virus (HIV) 1 or 2.
- •2)Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using adequate acceptable contraceptive measures, as judged by the Investigator.
- •3)Men not using acceptable contraceptive measures, as judged by the Investigator.
- •4)Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the subject or the objectives of the study, as judged by the Investigator.
- •5)Clinically relevant abnormalities in electrocardiogram (ECG), haematology, clinical chemistry, serology or urine chemistry, as judged by the Investigator.
- •6)Newly discovered unstable diabetes or ongoing renal disease including haemodialysis or peritoneal dialysis.
- •7)Concurrent severe illness in the gastrointestinal tract like paralysis or malabsorption, or clinically manifested jaundice.
- •8)Known liver cirrhosis.
- •9)Drug or alcohol abuse by asking the subject at screening.
- •10)Contraindications to MR imaging (e.g. aneurysm clip, pacemaker, or severe claustrophobia).
- •11)Known or suspected hypersensitivity to the investigational product or excipients of the investigational product.
- •12)Ongoing treatment with tetracycline or doxycycline.
- •13)Use of antidiarrhoea or antinausea drugs during the last 7 days preceding this study.
- •14)Participation in another clinical study during the last 3 months preceding this study or at any time during the participation in this study.
- •15)Investigations involving X-ray, MRI, nuclear medicine or ultrasound using intravenous or oral contrast medium within the period of 7 days before and 7 days after each dose in this study.
- •16)Previous inclusion in this study.
- •17)Any other reason that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.
研究者
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