A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Ciprofloxacin XR Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR
研究概览
简要总结
This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone & in combination with MMX Mesalazine/mesalamine.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ciprofloxacin + MMX placebo
干预措施: Ciprofloxacin XR + MMX Placebo (Drug)
MMX Mesalazine/mesalamine + Ciprofloxacin
干预措施: MMX Mesalazine/mesalamine + Ciprofloxacin XR (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR
时间窗: Assessed over a 24-hour period starting post-dose on day 4
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR
时间窗: Assessed over a 24-hour period starting post-dose on day 4
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
次要结局
未报告次要终点