NCT01457716已完成不适用
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Cmax of Budesonide and Formoterol
研究概览
简要总结
The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, 18-55 years of age.
- •Normal weight at least 50 kg.
排除标准
- •Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- •Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
- •Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
- •Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- •Pregnant or lactating females.
研究组 & 干预措施
Budesonide/Formoterol Easyhaler B
Experimental
干预措施: Budesonide (Drug)
Budesonide/Formoterol Easyhaler A
Experimental
干预措施: Easyhaler (Device)
Budesonide/Formoterol Easyhaler A
Experimental
干预措施: Budesonide (Drug)
Budesonide/Formoterol Easyhaler A
Experimental
干预措施: Formoterol (Drug)
Budesonide/Formoterol Easyhaler B
Experimental
干预措施: Formoterol (Drug)
Budesonide/Formoterol Easyhaler B
Experimental
干预措施: Easyhaler (Device)
Budesonide/Formoterol Easyhaler C
Experimental
干预措施: Budesonide (Drug)
Budesonide/Formoterol Easyhaler C
Experimental
干预措施: Formoterol (Drug)
Budesonide/Formoterol Easyhaler C
Experimental
干预措施: Easyhaler (Device)
Budesonide/Formoterol Turbohaler Forte
Active Comparator
干预措施: Budesonide (Drug)
Budesonide/Formoterol Turbohaler Forte
Active Comparator
干预措施: Formoterol (Drug)
Budesonide/Formoterol Turbohaler Forte
Active Comparator
干预措施: Turbohaler Forte (Device)
结局指标
主要结局
Cmax of Budesonide and Formoterol
时间窗: 24 hours
AUCt of Budesonide and Formoterol
时间窗: 24 hours
次要结局
- AUCinf of Budesonide and Formoterol(24 hours)
- tmax of Budesonide and Formoterol(24 hours)
- t1/2 of Budesonide and Formoterol(24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler ForteAsthmaNCT01627158Orion Corporation, Orion Pharma72
已完成
1 期
Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort TurbuhalerAsthmaNCT01593826Orion Corporation, Orion Pharma72
已完成
1 期
Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort TurbuhalerAsthmaNCT01386996Orion Corporation, Orion Pharma74
已完成
1 期
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder InhalerHealthyNCT00868426Orion Corporation, Orion Pharma12
已完成
1 期
Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort TurbuhalerAsthmaNCT03073057Orion Corporation, Orion Pharma20