NCT02431624已完成1 期
A Two Period, Randomised, Open-label, Crossover Study to Assess the Adhesion of Buprenorphine Transdermal Delivery System 40 µg/h Patch and 20 µg/h Patch, 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
- 40
- 试验地点
- 1
- 主要终点
- Patch Adhesion score
研究概览
简要总结
The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.
详细描述
The objective is to show non-inferiority in adhesion of BTDS patch 40 µg/h compared to BTDS patch 20 µg/h. Safety and tolerability of both patches will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Test treatment
Experimental
BTDS 40 milligram
干预措施: BTDS (Drug)
Reference treatment
Active Comparator
BTDS 20 milligram
干预措施: BTDS (Drug)
结局指标
主要结局
Patch Adhesion score
时间窗: 7 days
次要结局
- Observer Rating Scale of Patch prior to Removal questionnaire(7 days)
- Skin reaction assessment score(day 8)
- Adverse Events(Up to 7-10 days post patch removal)
- Changes in haematology and biochemistry values(Up to 7-10 days after last patch removal)
- Vital signs(Up to 7-10 days after last patch removal)
- ECG(Up to 7-10 days after last patch removal)
研究者
研究点 (1)
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