EUCTR2009-011097-15-AT进行中（未招募）不适用
Effect of atypical antipsychotics on gene expression in soft tissues of healthy subjects. A placebo controlled randomised pilot study. - OLA_ZIPRA
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie0 个研究点开始时间: 2009年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •Healthy, defined as absence of relevant diseases
- •Aged 18-45 years
- •BMI: 18-25 kg/m2
- •Signed informed consent
- •No signs of impaired glucose tolerance as evaluated by OGTT before study inclusion during screening, normal total cholesterol, HDL, LDL, triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator
- •No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator
- •History of hypertension, RR > 140/90 at screening, cardiovascular disease
- •Body mass index out of the range of <18 and >25 kg/m
- •HIV or Hepatitis B/C positive virology
- •Allergy or hypersensitivity against olanzapin/ziprasidon or another excipient
- •Contraindications against the use of the drug according to the SmPC
- •Any drug intake 2 weeks prior to first study day
- •History of excessive bleeding tendency / hemophilia
- •Presence of relevant illness within the last 3 weeks
- •Suspected non-compliance with study instructions and life-style requirements
- •History of alcohol or drug abuse
- •Blood/Plasma donation within 4 weeks prior to study day
- •Previous exposure to antipsychotic drugs
- •Nicotine consumption at time of enrolment (at least 3 months of non-smoking required)
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