The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Leukocyte radical oxygen species (ROS) production
研究概览
简要总结
The purpose of this study is to determine whether paracetamol, ibuprofen or their combination can modify generation of radical oxygen species (ROS) from stimulated neutrophils.
详细描述
Non-steroidal anti-inflammatory drugs (NSAID) are used to alleviate clinical inflammatory symptoms (e.g. pain, swelling and reduced function). Leukocytes, upon activation during inflammatory states, generate radical oxygen species (ROS) which primarily are intended for host defence against invading pathogens. Certain NSAID can modify the generation of ROS from stimulated neutrophils ranging form increased production to reduced production. Preliminary experiments in our laboratory have shown that different NSAIDs have opposing effects on the ability of leukocytes (granulocytes and monocytes) to produce ROS upon a standardized stimulus, i.e. phorbol myristate acetate (PMA). Paracetamol has a marked inhibitory effect and ibuprofen has a facilitating effect on ROS production. An inhibitory effect of paracetamol was also seen when examining platelet activation markers, whereas acetylsalicylic acid showed a clear enhancing effect in this respect. We want to examine if intake of paracetamol or ibuprofen in vivo have similar effects on leukocyte ROS production and platelet activation, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers of both sexes (ASA type I).
- •Females who are not pregnant or plan conception. (A pregnancy test will be conducted before each test day)
- •Persons who have not used analgesics for 3 days prior to the blood sampling.
- •Persons without known active peptic ulcer or gastrointestinal bleeding.
- •Persons without any known hypersensitivity for NSAIDs.
- •Persons under no other drug treatment than contraceptives.
- •Age 18 to 35 years of Caucasian origin
排除标准
- •Pregnancy during the test period.
- •Development of active peptic ulcer during the test period.
- •Change in medication status during the test period (after inclusion).
研究组 & 干预措施
Ibuprofen 400 mg
Ibuprofen oral single dose
干预措施: Ibuprofen (Drug)
Ibuprofen 1200 mg
Ibuprofen oral single dose
干预措施: Ibuprofen (Drug)
Paracetamol (acetaminophen) 1000 mg
Paracetamol (acetaminophen) oral single dose
干预措施: Paracetamol (acetaminophen) 1000 mg (Drug)
Ibuprofen 400 mg + paracetamol 1000 mg
Paracetamol (acetaminophen) + ibuprofen oral single dose
干预措施: Paracetamol + ibuprofen (Drug)
结局指标
主要结局
Leukocyte radical oxygen species (ROS) production
时间窗: 24 hours for each crossover event
次要结局
- Platelet activation status(24 hours for each crossover event)
