NCT02184247已完成1 期
A Study to Compare the Bioavailability of Two Sustained-release Theophylline Products
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg theophylline anhydrous (sustained-release product) by comparing the rate and extent of absorption of theophylline based on both single and multiple-dose profiles.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking male subjects between 18 and 45 years of age
- •Body weight within 10% of the ideal weight according to the Body Mass Index (BMI)
- •Normal health based on medical history and findings within the range of clinical acceptability, in respect of the physical examination (including electrocardiogram and vital signs) and special investigations
- •Ability to comprehend and willingness to sign both statements of informed consent (for screening and study-specific procedures)
排除标准
- •History of serious systemic or organ disease
- •A major illness during the 3 months before commencement of the study-related procedures
- •Significant physical or organ abnormality
- •History of hypersensitivity to theophylline or other xanthine derivatives
- •Use of any medication within 2 weeks before the first administration of study medication
- •Participation in another study with an experimental drug within 8 weeks before the first administration of study medication
- •Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system (for example chloramphenicol, which may cause bone marrow suppression)
- •Donation of blood during the 8 weeks before the first administration of study medication
- •History of, or current compulsive alcohol abuse (> 10 drinks per week), of regular exposure to other substance of abuse
- •Positive testing for HIV and hepatitis B antigens within the previous 3 months
研究组 & 干预措施
anhydrous theophylline, 350 mg
Experimental
干预措施: anhydrous theophylline, 350 mg (Drug)
anhydrous theophylline, 300 mg
Active Comparator
干预措施: anhydrous theophylline, 300 mg (Drug)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)
时间窗: up to 36 hours after first drug administration
Area under the plasma concentration versus time data pairs at steady state (AUDss)
时间窗: up to 12 hours after last administration of study drug
Percent peak-to-trough fluctuation (%PTF)
时间窗: up to 12 hours after last administration of study drug
次要结局
- Apparent terminal half-life (t1/2.z)(up to 36 hours after first drug administration)
- Total mean time in the system (MTvsys)(up to 36 hours after first drug administration)
- Minimum concentration at steady state (Cmin,ss)(up to 12 hours after last administration of study drug)
- Plateau time (T75%Cmax)(up to 12 hours after last administration of study drug)
- Time to maximum concentration (Tmax)(up to 36 hours after first drug administration)
- Area under the plasma concentration versus time data pairs [AUD(0-tlast)], also indicated by AUD, where tlast is the time of the last quantifiable concentration(up to 36 hours after first drug administration)
- Maximum concentration at steady state (Cmax,ss)(up to 12 hours after last administration of study drug)
- Ratio of Cmax and AUDC (Cmax/AUDC)(up to 36 hours after first drug administration)
研究者
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