A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin in Serum, Bronchial Washings and Lung Tissue Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Resection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
研究概览
简要总结
The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar macrophages (AM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were hospitalized subjects diagnosed with lung cancer that had consented to surgery requiring lung resection who had a life expectancy of >6 months.
排除标准
- •Key exclusion criteria were antibiotic prophylaxis prior to surgery, diffuse, non-infectious lung disease, history of cigarette smoking of >5 packs per year, patients with any infectious disease that required antibiotic therapy, administration of drugs known to interfere with azithromycin pharmacokinetics, and subjects on chemotherapy.
研究组 & 干预措施
1
干预措施: azithromycin immediate release (Zithromax) (Drug)
1
干预措施: placebo (Other)
2
干预措施: azithromycin SR (Drug)
2
干预措施: placebo (Other)
结局指标
主要结局
Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
时间窗: predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
时间窗: 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
次要结局
- 12-lead electrocardiograms (ECGs)(Screening and 72 hours postdose)
- adverse events (AEs)(Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose)
- safety laboratory tests(Treatment day 0 and 72 hours postdose)
- vital signs(Screening and Treatment day 0)