NCT00964535已完成1 期
Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation
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
- 87
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
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 Turbohaler 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
- 否
入选标准
- •Males or females aged 18-60 years with documented diagnosis of asthma
- •Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
- •The asthma should be stable on the same regular treatment for at least 4 weeks before screening.
排除标准
- •Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
- •Respiratory infection within 4 weeks preceding the screening
- •Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
- •Any disorder or 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
研究组 & 干预措施
Budesonide/formoterol Easyhaler
Experimental
干预措施: budesonide and formoterol 200/6 microg (Drug)
Charcoal and Budesonide/formoterol EH
Experimental
干预措施: budesonide and formoterol 200/6 microg (Drug)
Symbicort Turbohaler
Active Comparator
干预措施: budesonide and formoterol 200/6 microg (Drug)
Charcoal and Symbicort Turbohaler
Active Comparator
干预措施: budesonide and formoterol 200/6 microg (Drug)
结局指标
主要结局
Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
时间窗: within 24 h
次要结局
未报告次要终点
研究者
研究点 (1)
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