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
- 129
- 试验地点
- 1
- 主要终点
- Cmax of plasma salmeterol and fluticasone propionate
研究概览
简要总结
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
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, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
- •Any condition requiring regular 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
Single dose of Salmeterol/fluticasone Easyhaler
干预措施: Salmeterol/fluticasone Easyhaler (Drug)
Salmeterol/fluticasone Easyhaler with charcoal
Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules)
干预措施: Salmeterol/fluticasone Easyhaler with charcoal (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 (Carbomix granules)
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: within 34 h
AUCt of plasma salmeterol and fluticasone propionate
时间窗: 34 h
次要结局
未报告次要终点