ACTRN12623000647639尚未招募1 期
The effect of Fomepizole on Oxidative Metabolism of Paracetamol: A Randomised Human Volunteer Crossover Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults at least 18 years of age
- •-No underlying liver disease (baseline liver function tests to be performed after recruitment)
- •-No regular medications except for vitamins or oral contraceptive pill
- •-No history of chronic alcohol, tobacco (smoker), or illicit drug use.
- •-Weigh less than 100 kg and BMI < 29 kg/m2
排除标准
- •-Pregnancy or lactation,
- •-Allergy to the medications administered in the study (paracetamol and fomepizole)
- •-Weight > 100kg or body mass index (BMI) > 29 kg/ m2 as obesity appears to increase activity of CYP2E1 and there are concerns of increased toxicity of paracetamol in the setting of non-alcoholic fatty liver disease.
- •-Pregnancy (females of child-bearing age to have urine BHCG).
- •-Pre-existing liver disease,
- •-Chronic alcohol consumption greater than 20 g per day,
- •-Any chronic illness,
- •-On regular medications (except for vitamins or the oral contraceptive pill)
- •-Before participation in the study, if on screening tests any abnormality in liver function tests performed 1 week before the study and 3 days after the first arm of the study.
研究者
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