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临床试验/EUCTR2022-001603-40-NL
EUCTR2022-001603-40-NL进行中(未招募)1 期

Combined effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on breathing: an exploratory study in healthy volunteers the POLO study - POLO study

eiden University Medical Center0 个研究点目标入组 24 人开始时间: 2022年6月21日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
24

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

  • - aged 18-45 years,
  • - body mass index < 30 kg.m-2,
  • - able to understand the written informed consent form,
  • - able to communicate with the staff,
  • - able and willing to complete the study procedures,
  • - signed the informed consent form,
  • - deemed suitable by the investigators.
  • 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 24
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome such as fibromyalgia);
  • - Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers);
  • - Use of more than 21 alcohol units per week;
  • - A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment;
  • - Pregnancy, lactating or a positive pregnancy test on the morning of the experiment;
  • - Participation in another drug trial in the 60 days prior to dosing.

研究者

发起方
eiden University Medical Center

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