A Randomised, Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of GW685698X and GW642444M When Administered Separately and in Combination as a Single Dose From a Novel Dry Powder Device in Healthy Subjects
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
- Electrocardiogram
研究概览
简要总结
A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 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
arm 1
study drug
干预措施: GW685698X & GW642444M (Drug)
结局指标
主要结局
Electrocardiogram
时间窗: changes over 12 hours.
Maximum heart rate
时间窗: over 4 hours after dosing.
Blood pressure
时间窗: changes over 12 hours.
Change in peak expiry flow rate
时间窗: changes over 24 hours.
Change in serum cortisol concentration
时间窗: changes over 24 hours.
次要结局
- Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)(over 48 hours after dosing.)
- Change in blood potassium levels(within 4 hours of drug dosing.)
- Mean heart rate(over 4 hours after dosing)