NCT00162786终止4 期
Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
J. Uriach and Company2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Actual driving performance
研究概览
简要总结
The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers' performance on a standard over-the-road driving test and a car-following test.
详细描述
The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows.
- Rupatadine
- Hydroxyzine
- Placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy males or females
- •Subjects must be experienced drivers.
- •Vision: normal binocular acuity, corrected, or uncorrected.
排除标准
- •1. Pregnant or nursing females.
结局指标
主要结局
Actual driving performance
次要结局
- Daytime sleepiness
- Subjective sleepiness
- Alertness
研究者
研究点 (2)
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