NCT01386996已完成1 期
Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, 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
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter Cmax of plasma budesonide concentration
研究概览
简要总结
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy males and females aged 18-60 years.
- •Normal weight, at least 50 kg.
- •Exclusion criteria
- •Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- •Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- •Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- •Known hypersensitivity to the active substance(s) or the excipient of the drug.
- •Pregnant or lactating females.
排除标准
- 未提供
研究组 & 干预措施
Charcoal and Budesonide/formoterol Easyhaler
Experimental
干预措施: Budesonide/formoterol Easyhaler 320/9 microg (Drug)
Charcoal and Symbicort Turbuhaler
Active Comparator
干预措施: Symbicort Turbuhaler forte (Drug)
Budesonide/formoterol Easyhaler
Experimental
干预措施: Budesonide/formoterol Easyhaler 320/9 microg (Drug)
Symbicort Turbuhaler
Active Comparator
干预措施: Symbicort Turbuhaler forte (Drug)
结局指标
主要结局
Pharmacokinetic parameter Cmax of plasma budesonide concentration
时间窗: within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration
时间窗: 12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration
时间窗: 24 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration
时间窗: 24 h
次要结局
未报告次要终点
研究者
研究点 (1)
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