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临床试验/EUCTR2018-003515-22-NL
EUCTR2018-003515-22-NL进行中(未招募)1 期

Respiratory effects of tapentadol and oxycodone assessed by pharmacokinetic-pharmacodynamic and response surface modeling in healthy volunteers - SURF

eiden University Medical Center0 个研究点目标入组 24 人开始时间: 2018年10月9日最近更新:
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相关药物

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

入选标准

  • Healthy male and female volunteers 18-38 years
  • 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

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • - Presence of health issues including presence or history of any psychiatric, medical or neurologic disorder that may interfere with the current study (eg. neuropathic pain conditions);
  • - Presence or a history of illicit drug use or excessive alcohol consumption (>21 units per week),
  • - Known allergies to study medication.
  • - A positive drug screen on the day of screening or on any of the study days,
  • - Participation in another trial in the 3 months before enrolment,
  • - Use of medication on a regular basis (e.g. pain medication),
  • - Inability to fast for at least 8 hours prior to study treatment administration,
  • - Pregnancy or lactation,
  • - Inability to communicate with the research team
  • - surgery during the study period.

研究者

发起方
eiden University Medical Center

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