NCT01423305已完成1 期
Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol
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
- 20
- 试验地点
- 1
- 主要终点
- The evaluation of primary pharmacokinetic variable AUCt
研究概览
简要总结
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
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
- •Healthy males and females aged 18-60 years.
- •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 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 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 excipients of the drug.
- •Pregnant or lactating females.
研究组 & 干预措施
Treatment A
Experimental
Budesonide/formoterol capsule (Orion Pharma) for oral administration.
干预措施: Budesonide/formoterol capsule. (Drug)
Treatment B
Experimental
Budesonide/formoterol capsule (Orion Pharma) for oral administration.
干预措施: Budesonide/formoterol capsule for oral adm. (Drug)
结局指标
主要结局
The evaluation of primary pharmacokinetic variable AUCt
时间窗: 4 weeks
The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.
次要结局
- Pharmacokinetic variables(4 weeks)
- Pharmacokinetic variable(4 weeks)
研究者
研究点 (1)
Loading locations...
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