NCT02218658已完成1 期
The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) Taken Without Water and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis) Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
研究概览
简要总结
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Age between 20 and 35 years
- •Weight between 50 and 80 kg
- •Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
- •Judged as eligible as a study object following the screening test by the investigator
- •Volunteers to participate in the study, who are capable of giving written informed consent
排除标准
- •Known hypersensitivity to drugs
- •History of drug or alcohol abuse
- •Received other investigational drug within 4 months of the trial drug administration
- •Had > 400 mL of whole blood drawn within 3 months of the trial drug administration
- •Had > 400 mL of blood components drawn within 1 month of the trial drug administration
- •Used any drug within 10 days of the trial drug administration
- •Engaged in strenuous exercise within 5 days of the trial drug administration
- •Consumed alcohol within 3 days of the trial drug administration
- •Judged as ineligible for the study participation by the investigator for a reason other than above
研究组 & 干预措施
WE 941 OD
Experimental
干预措施: WE941 OD tablets (Drug)
Brotizolam
Active Comparator
干预措施: Brotizolam (Drug)
结局指标
主要结局
AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
时间窗: up to 24 hours after drug administration
Cmax (maximum plasma concentration)
时间窗: up to 24 hours after drug administration
次要结局
- Number of patients with adverse events(up to 30 days)
- tmax (time to maximum plasma concentration)(up to 24 hours after drug administration)
- MRT (Mean residence time)(up to 24 hours after drug administration)
研究者
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