NCT00712283已完成1 期
A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Group Design Study to Investigate the Effect of 12,5 mg, 25 mg, 50 mg and 75 mg Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Fitness to drive
研究概览
简要总结
Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers, female and male
- •age 21 - 50
- •BMI 18 - 30 kg/m2
- •experienced drivers with a valid driver's license and at least 3 years of driving practice
排除标准
- •any clinically relevant finding on physical examination affecting the study objectives
- •clinically relevant abnormalities in the ECG laboratory values
- •history or present evidence of clinically relevant metabolic, renal, hepatic, pulmonary or cardiovascular disease, CNS disorders, or disturbance of bleeding diagnosis of malignancy
- •females who are pregnant or breastfeeding
研究组 & 干预措施
D
Placebo Comparator
healthy volunteers
干预措施: Neramexane mesylate (Drug)
C
Active Comparator
healthy volunteers
干预措施: Neramexane mesylate (Drug)
B
Active Comparator
healthy volunteers
干预措施: Neramexane mesylate (Drug)
A
Active Comparator
healthy volunteers
干预措施: Neramexane mesylate (Drug)
结局指标
主要结局
Fitness to drive
时间窗: 15 days
次要结局
- Psychometric test and motor control tests(15 days)
研究者
研究点 (1)
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