NCT00878540已完成1 期
Phase 1 Study of Mirtazapine in Healthy Subjects
Max-Planck-Institute of Psychiatry1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
研究概览
简要总结
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 20-25 years
- •Somatically and mentally healthy
- •Normal body weight (body mass index (BMI)18.5-25)
排除标准
- •Smoking within the last 6 months
- •Medication within last 6 months
- •Current or former psychiatric illness
- •Positive family history (first grade relatives) for metabolic diseases
- •Alcohol abuse
- •Current or former illicit drug abuse
- •Current or former drug abuse
- •Known intolerance to, or former prescription of study medication
- •Participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months
- •Homelessness
- •Shift work within last 12 months
- •Known hypersensitivity to mirtazapine or other components of the drug given
- •Known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease
- •Known hematologic disease, especially agranulocytosis or leukopenia
- •Blood donation within last 6 months prior to the begin of the study
- •Hemoglobin below 13.5 mg/dL
研究组 & 干预措施
mirtazapine
Experimental
干预措施: mirtazapine (Drug)
结局指标
主要结局
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
时间窗: 3 days
次要结局
未报告次要终点
研究者
研究点 (1)
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