A Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Azithromycin on the Steady-State Plasma Levels of Theophylline in a Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- steady-state plasma concentration of theophylline
研究概览
简要总结
Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere with the pharmacokinetics of many other drugs that are metabolised by this enzyme like theophylline.The aim of this study is to determine whether azithromycin can effect theophylline metabolism in patients.
详细描述
In this non-blinded,auto-control study,patients with Chronic Obstructive Pulmonary Disease（COPD）or asthma will serve as their own controls during the 2-week treatment phase.The subjects will be co-administered oral doses of sustained release theophylline (100mg tablets,twice daily) and azithromycin (2x250mg capsules,once daily )in the first week.Then patients will received theophylline therapy alone with the same dose in the second week.Blood samples for the measurement of theophylline plasma concentrations will be collected on Days 8 and 15 prior to dosing.All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with COPD or asthma，aged 18-75 years;
- •regularly visiting our hospital;
- •meeting the indications for azithromycin and theophylline simultaneously;
排除标准
- •patients with renal or hepatic dysfunction;
- •patients with congestive heart failure;
- •patients with hypothyroidism or hyperthyroidism;
- •patients taking drugs likely to affect the theophylline metabolism in the preceding week;
- •patients with severe chronic obstructive pulmonary disease,asthma or respiratory infection;
研究组 & 干预措施
Theophylline with azithromycin
steady-state plasma concentration of theophylline in the presence of azithromycin
干预措施: Theophylline with azithromycin (Drug)
Theophylline alone
steady-state plasma concentration of theophylline alone
干预措施: Theophylline alone (Drug)
结局指标
主要结局
steady-state plasma concentration of theophylline
时间窗: blood samples for theophylline will be collected on Days 8 and 15 before dosing
Theophylline and it's metabolite(1,3-dimethyluric) blood concentration
次要结局
未报告次要终点