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临床试验/ISRCTN16578656
ISRCTN16578656已完成未知

Observational study to evaluate inter-and intra-subject variability of microcirculatory and endothelial functional tests and differences in these tests between several subject populations

Centre for Human Drug Research0 个研究点目标入组 8 人开始时间: 2022年3月7日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
8

研究概览

简要总结

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37177864/ (added 04/04/2024)

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • 1. Male and females, 18 to 30 years of age, inclusive.
  • 2. Subject has voluntarily signed informed consent form.
  • 3. Willingness and ability to comply with all study procedures
  • 4. Body mass index (BMI) between 18 and 30 kg/m²

排除标准

  • 1. Evidence of any active or chronic disease or condition that could interfere with the conduct of the study (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
  • 2. Receival of any study drug within 30 days or 5 times ½ half-life, whichever greater prior to day 1.
  • 3. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study).
  • 4. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent.
  • 5. Alcohol intake 24h prior to the study day.
  • 6. Is demonstrating excess in caffeine consumption (more than eight cups of coffee or equivalent per day.
  • 7. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study
  • 8. Any daily nicotine use or regular use of nicotine products.
  • 9. Positive nasopharyngeal rapid antigen test for SARS-CoV-2 at admission to the clinical research center
  • 10. Subject has received any vaccination in the last 2 weeks prior to Visit 1

研究者

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