A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (Tamiflu®) in Patients in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .
研究概览
简要总结
This proposed pharmacokinetic study will test the hypothesis that in critically ill patients with respiratory failure requiring mechanical ventilation such as might be anticipated to be needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults ill with influenza in whom oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this experiment will test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and urinary recovery of drug from 0 to 48 hrs after administration.
详细描述
Not required
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •patients admitted to the Intensive Care Unit requiring mechanical ventilation due to respiratory failure
- •must be within the ages of 18-75 yrs
排除标准
- •patients unable to have enteral feeding
- •intolerance to oseltamivir
- •pregnancy
- •gastrointestinal or malabsorptive disease
- •intestinal bypass surgery
- •diarrhea (>2 loose bowel movements per day)
- •receipt of prokinetic medications (metoclopramide, domperidone, erythromycin)
- •severe liver disease (hepatocellular enzymes > 3 times the upper limit of normal)
- •renal failure (Cockroft-Gault Creatinine Clearance < 30 ml/min, Dialysis dependant)
- •cystic fibrosis
- •intoxication or drug overdose
研究组 & 干预措施
A.Oseltamivir 75 mg dose
Patients will be randomized to two groups (group A) to receive oseltamivir at 75 mg, or (group B) to receive the drug at 150 mg in the fasting or fed state.
干预措施: Oseltamivir 75 mg (Drug)
B. Oseltamivir 150mg
Patients will be randomized to groups (group A) to receive oseltamivir at 75 mg, or group B to receive the drug at 150 mg in the fasting or fed state.
干预措施: Oseltamivir 75 mg (Drug)
结局指标
主要结局
Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .
时间窗: 13 months
次要结局
- Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.(13 months)
研究者
Dr. Faisal Siddiqui
Principal Investigator MD
University of Manitoba