NCT00315601终止4 期
Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters
研究概览
简要总结
The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.
详细描述
The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Between 18 and 55 years, inclusive, of age
- •No history of smoking within the last 1 year
- •Body weight within +/- 15% of the Metropolitan Life Insurance Company tables
- •No clinically important abnormalities in the medical history or physical exam
- •Female subjects of childbearing potential must have a negative pregnancy test
- •Female subjects of childbearing potential must use reliable methods of birth control
排除标准
- •Allergy to telithromycin, azithromycin, or any macrolide antibiotic
- •Allergy or serious adverse reactions to benzodiazepines or lidocaine
- •History of renal, gastrointestinal, or liver disease
- •Significant hypertension
- •Clinically significant heart or pulmonary diseases
- •History of drug or alcohol dependence within 12 months of study entry
- •Positive pregnancy test
- •Currently breast feeding
- •Use of any drug within 2 weeks of study entry
- •Received an investigational drug within 30 days of study entry
结局指标
主要结局
Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters
时间窗: 7 days
次要结局
- How long does the study antibiotics get into the fluids and cells of the lung.(7 days)
研究者
研究点 (2)
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