Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µg/Inhalation: A Randomised, Open, Single Centre, Single Dose, Crossover Study 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
- Cmax of plasma salmeterol and fluticasone propionate
研究概览
简要总结
Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects
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
- •written informed consent obtained
- •good general health ascertained by detailed medical history, and laboratory and physical examinations
排除标准
- •evidence of a clinically significant cardiovascular, renal, hepatic, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
- •any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed
- •known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
- •pregnant or lactating females
研究组 & 干预措施
Salmeterol/fluticasone Easyhaler with charcoal
Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration
干预措施: Salmeterol/fluticasone Easyhaler with charcoal (Drug)
Salmeterol/fluticasone Easyhaler
single dose of Salmeterol/fluticasone Easyhaler
干预措施: Salmeterol/fluticasone Easyhaler (Drug)
Seretide Diskus
Single dose of Seretide Diskus
干预措施: Seretide Diskus (Drug)
Seretide Diskus with charcoal
Single dose of Seretide Diskus with concomitant charcoal administration
干预措施: Seretide Diskus with charcoal (Drug)
结局指标
主要结局
Cmax of plasma salmeterol and fluticasone propionate
时间窗: 0 hour to 34 hours after study treatment administration
AUCt of plasma salmeterol and fluticasone propionate
时间窗: 0 hour to 34 hours after study treatment administration
次要结局
未报告次要终点