A Four-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Dose Proportionality and Relative Bioavailability of Buprenorphine Transdermal Delivery System Second Generation Patches Compared to First Generation Patches, in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameters
研究概览
简要总结
The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation BTDS patches.
详细描述
The objective is to examine a new 2nd generation BTDS patch formulation at 2 strengths: 3.15 mg and 12.6 mg, compared to 1st generation patches at 2 strengths: 5 mg and 20 mg, to assess dose proportionality and relative bioavailability before proceeding to a definitive program of studies. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application.
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
Treatment A
Second generation patch BTDS 12.6mg
干预措施: Second generation BTDS patch (Drug)
Treatment B
Second generation patch BTDS 3.15mg
干预措施: Second generation BTDS patch (Drug)
Treatment C
First generation patch BuTrans 20mg
干预措施: First generation BuTrans patch (Drug)
Treatment D
First generation patch BuTrans 5mg
干预措施: First generation BuTrans patch (Drug)
结局指标
主要结局
Pharmacokinetics parameters
时间窗: Up to 288 hours
AUC and Cmax
次要结局
- Adverse events(7 to 10 days)