DRKS00015049已完成未知
A single-center, open pilot trial to investigate the performance of the modified intravascular microdialysis probe MicroEye® in healthy subjects - iCGM_01
A. Menarini Diagnostics S.r.l.0 个研究点目标入组 20 人开始时间: 2018年8月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 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
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Informed consent obtained after being advised of the nature of the study
- •2. Male or female aged 18 - 75 years (both inclusive)
- •3. Healthy volunteer
- •4. Body mass index 20.0 - 29.5 kg/m² (both inclusive)
- •5. Availability of veins (within the forearms) suitable for insertion of three intravenous lines (two for microdialysis sampling and one for reference blood withdrawal).
排除标准
- •1. Female of childbearing potential who is pregnant, breast-feeding or intending to become pregnant or is not using adequate contraceptive methods
- •2. Skin pathology or condition prohibiting needle insertion as judged by the Investigator
- •3. History of bleeding disorder
- •4. History of heparin-induced thrombocytopenia (HIT)
- •5. Current participation in another clinical study
- •6. Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the Investigator
- •7. Drugs which have an influence on glucose metabolism such as: systemic (oral or i.v.) corticosteroids, anticoagulation medication, monoamine oxidase (MAO) inhibitors or paracetamol. Thyroid hormones are not allowed unless the use of these has been stable during the past 1 month.
- •8. Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day
- •9. Known hypersensitivity to Fondaparinux sodium (Arixtra ®)
- •10. Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen
研究者
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