EUCTR2015-005056-96-ES进行中（未招募）1 期
se of tramadol in healthy volunteers.Effects on physical performance and sustained attention in cycling.
Daniel Sanabria Lucena0 个研究点开始时间: 2016年1月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- All
入选标准
- •- Signed informed consent before any activity related with the study, including assessments required for the selection.
- •- Age between 18 and 35 years inclusive.
- •- If women would find no confirmation pregnant or breastfeeding and commitment to use adequate contraception as hormonal contraception, intrauterine device or barrier methods (vaginal condom or diaphragm) along the entire study period.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Allergy to tramadol or any of the excipients
- •- Any symptoms of heart disease
- •- Metabolic disorder such as obesity (BMI> 30) or diabetes
- •- Chronic obstructive pulmonary disease (COPD)
- •- Epilepsy or seizure risk as withdrawal
- •- Active treatment with beta-blockers
- •- Patients treated with MAO inhibitors or that they have received
- •Over the past 14 days
- •- Consumption of alcohol, snuff or other drugs of abuse that could
- •incapacitate to participate in the study.
- •- Diagnosis of any other condition that the investigator's opinion, may
- •increase the risk of the subject or reduce the chances of obtaining data
- •satisfactory to achieve the objectives of the study.
研究者
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