NCT02218671已完成1 期
Clinical Pharmacological Study on Absorption From Mucous Membrane of Oral Cavity of WE 941 OD Tablets
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
- 10
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE 941 OD tablets are administered in Japanese healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •age 20 - 35 years
- •body weight 50 - 80 kg
- •Body Mass Index (BMI) +/- 20%
排除标准
- 未提供
研究组 & 干预措施
WE 941 OD under deglutition
Experimental
干预措施: WE 941 OD tablets (Drug)
WE 941 OD under non-deglutition
Experimental
干预措施: WE 941 OD tablets (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 17 days
次要结局
- Maximum concentration of the analyte in plasma (Cmax)(up to 24 hours)
- Cmax ratio for non-deglutition to deglutition(up to 24 hours)
- Area under the plasma concentration-time curve from zero to 24hours (AUC0-24 )(up to 24 hours post dose)
研究者
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