EUCTR2017-000997-13-DK进行中（未招募）1 期
Pharmacokinetics of intravenous, rectal, intravesical, vaginal, and transdermal administration of exogenous melatonin in healthy female volunteers: a crossover study
Center for Perioperative Optimization, Department of Surgery, Herlev Hospital0 个研究点目标入组 10 人开始时间: 2017年11月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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 female
- •20-40 years old
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inability to understand Danish, written or spoken.
- •Current use of melatonin or other hypnotics/sedatives
- •Current pregnancy (a positive urine-HCG; the subjects will be tested prior to each study session)
- •Breast feeding
- •Current alcohol or drug abuse (defined as over 5 units of alcohol per day, or any usage of illegal drugs)
- •Mental illness (defined as being in medical treatment)
- •Serious comorbidity (American Society of Anesthesiologists (ASA) physical status 3-4)
- •Participation in other clinical trials less than 1 month prior to current study
- •Night-shift work within the last 14 days prior to study
- •Planned night-shift work within the study period
- •Known and diagnosed sleep-disorder (defined as being in current medical treatment)
研究者
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