Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: 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
- 20
- 试验地点
- 1
- 主要终点
- AUCt of plasma budesonide and formoterol
研究概览
简要总结
The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
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
- •Body mass index > 19 and < 30kg/m2, weight at least 50 kg
- •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
- •Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
- •Known hypersensitivity to the active substance(s) or the excipient of the drug
- •Pregnant and lactating females
研究组 & 干预措施
Charcoal and Budesonide/formoterol Easyhaler A
160/4.5microg/inhalation Charcoal
干预措施: Budesonide/formoterol (Drug)
Charcoal and Budesonide/formoterol Easyhaler A
160/4.5microg/inhalation Charcoal
干预措施: Charcoal (Other)
Charcoal and Budesonide/formoterol Easyhaler B
160/4.5microg/inhalation Charcoal
干预措施: Budesonide/formoterol (Drug)
Charcoal and Budesonide/formoterol Easyhaler B
160/4.5microg/inhalation Charcoal
干预措施: Charcoal (Other)
Charcoal and Budesonide/formoterol Easyhaler C
160/4.5microg/inhalation Charcoal
干预措施: Budesonide/formoterol (Drug)
Charcoal and Budesonide/formoterol Easyhaler C
160/4.5microg/inhalation Charcoal
干预措施: Charcoal (Other)
Charcoal and Symbicort Turbuhaler
160/4.5microg/inhalation Charcoal
干预措施: Charcoal (Other)
Charcoal and Symbicort Turbuhaler
160/4.5microg/inhalation Charcoal
干预措施: Symbicort Turbuhaler (Drug)
结局指标
主要结局
AUCt of plasma budesonide and formoterol
时间窗: within 24 hours
Cmax of plasma budesonide and formoterol
时间窗: within 24 hours
次要结局
未报告次要终点