A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameters AUC and Cmax
研究概览
简要总结
To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.
详细描述
This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.
Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
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
12 hourly capsule fasted
4 mg 12 hourly capsule - strong pain killer fasted
干预措施: 4 mg 12 hourly capsule - strong pain killer fed (Drug)
12 hourly capsule fed
4 mg 12 hourly capsule - strong pain killer fed
干预措施: 4 mg 12 hourly capsule - strong pain killer fasted (Drug)
12 hourly capsule with antagonist fasted
4 mg 12 hourly capsule strong painkiller with antagonist fasted
干预措施: 4 mg 12 hourly capsule strong painkiller with antagonist fed (Drug)
12 hourly capsule with antagonist fed
4 mg 12 hourly capsule strong painkiller with antagonist fed
干预措施: 12 hourly capsule strong painkiller with antagonist fasted) (Drug)
结局指标
主要结局
Pharmacokinetics parameters AUC and Cmax
时间窗: Up to 32 hours
次要结局
- Adverse Events(7 to 10 days)
- Vital Signs(0 to 32 hours)
- Clinical Laboratory Tests(Day 0 and Day 7-10)
- ECG(Screening, 1 our post-dose and Day 7-10)