NCT00868426已完成1 期
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler, Symbicort Turbuhaler; an Open, Single Center, Single Dose Study With 3-way Crossover Design 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
- 12
- 试验地点
- 1
- 主要终点
- Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage
研究概览
简要总结
The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.
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
- •Good general health ascertained by detailed medical history, and laboratory and physical examinations
- •Finnish speaking males and females, 18-55 (inclusive) years of age
- •Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2
- •Weight at least 50 kg
- •Regular intestinal transit
排除标准
- •Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
- •Any abnormal value of laboratory, vital signs, 12-lead electrocardiogram or physical exam which may in the opinion of the investigator interfere with the test results or cause a health risk for the subject if he/she takes part into 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 to any of the excipients of the drug
- •Pregnant or lactating females
- •Recent or current (suspected) drug abuse or positive result in the drugs abuse test
- •Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent])
- •Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study
- •Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration
- •Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
- •Administration of another investigational drug within 90 days prior to the first study treatment administration
- •Unsuitable veins for repeated venipuncture or for cannulation
- •Inability to learn the correct inhalation technique
- •Inability to participate in all treatment periods
研究组 & 干预措施
1
Experimental
Budesonide/Formoterol Batch 1
干预措施: Budesonide/Formoterol Batch 1 (Drug)
2
Experimental
Budesonide/Formoterol Batch 2
干预措施: Budesonide/Formoterol Batch 2 (Drug)
3
Experimental
Budesonide/Formoterol Batch 1 and charcoal
干预措施: Budesonide/Formoterol Batch 1 and charcoal (Drug)
结局指标
主要结局
Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage
时间窗: 1 day
次要结局
- Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler(1 day)
研究者
研究点 (1)
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