Oseltamivir Pharmacokinetics in Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Serum Drug Concentration
研究概览
简要总结
This trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given to people who have influenza, and currently is also being used to fight the new H1N1 influenza. Some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. No studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half of the people will be of normal body weight and the others will be of a much higher than normal body weight. Using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Males and females aged 18 to 55 years
- •Written informed consent
- •Subjects without medical history, physical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol.
排除标准
- •Allergy to oseltamivir
- •Blood donation within 3 months before oseltamivir administration
- •Medications that may interfere with the disposition of oseltamivir (e.g. probenecid)
- •Estimated Creatinine clearance < 60 ml/min (As calculated by the modified Cockcroft Gault equation below) Creatinine Clearance= (140-Age) x 1.2 x Adjusted Body weight (x 0.85 if female) Serum Creatinine (umol/L)
- •Adjusted body weight = Ideal body weight + [0.4 (Actual Bodyweight-Ideal Body Weight)]
- •Gastrectomy
- •Enterectomy (or any other surgical procedure that would interfere with absorption)
- •Clinically significant haematological (RBC count, WBC count, WBC differential count, platelets count and haemoglobin level) or biochemical (ALT, AST, creatinine and urea) abnormalities as per the judgement of the investigator
- •Clinically significant cardiac conduction abnormality noted on baseline electrocardiogram.
- •Influenza like illness (fever and/or cough plus one of the following sore throat, fatigue, myalgia, headache) within 7 days of enrolment
- •Pregnancy
- •Inability to consume study meals provided due to special dietary requirements such as food allergies.
结局指标
主要结局
Serum Drug Concentration
时间窗: 7 Days
次要结局
未报告次要终点