Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of salmeterol
研究概览
简要总结
The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus
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
- 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
Seretide Diskus
salmeterol-fluticasone 2 inhalations as a single dose
干预措施: salmeterol-fluticasone (Drug)
Salmeterol/fluticasone Easyhaler, E
salmeterol-fluticasone 2 inhalations as a single dose
干预措施: salmeterol-fluticasone (Drug)
Salmeterol/fluticasone Easyhaler, F
salmeterol-fluticasone 2 inhalations as a single dose
干预措施: salmeterol-fluticasone (Drug)
Salmeterol/fluticasone Easyhaler, G
salmeterol-fluticasone 2 inhalations as a single dose
干预措施: salmeterol-fluticasone (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of salmeterol
时间窗: between 0-34 hours after dosing
Cmax of salmeterol
Truncated area under the plasma concentration versus time curve (AUC) of salmeterol
时间窗: 0-30 minutes after dosing
AUC from time zero to 30 min after study treatment administration
Peak plasma concentration (Cmax) of fluticasone propionate
时间窗: between 0-34 hours after dosing
Cmax of fluticasone propionate
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
时间窗: 0-34 hours after dosing
AUC from time zero to the last sample with the quantifiable concentration
Area under the plasma concentration versus time curve (AUC) of salmeterol
时间窗: 0-34 hours after dosing
AUC from time zero to the last sample with the quantifiable concentration
次要结局
- Area under the plasma concentration versus time curve (AUC) of salmeterol(0-34 hours after dosing and extrapolation)
- The terminal elimination half-life (t1/2) of fluticasone propionate(0-34 hours after dosing)
- Area under the plasma concentration versus time curve (AUC) of fluticasone propionate(0-34 hours after dosing and extrapolation)
- The time to reach the maximum concentration (tmax) of salmeterol(0-34 hours after dosing)
- The time to reach the maximum concentration (tmax) of fluticasone propionate(0-34 hours after dosing)
- The terminal elimination half-life (t1/2) of salmeterol(0-34 hours after dosing)