NCT03878693已完成早期 1 期
The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Oxidative metabolism of APAP
研究概览
简要总结
Oxidative metabolism of APAP will be studied with and without 4-MP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •No APAP use in previous 2 weeks
- •No ingestion of alcohol or drugs that affect CYP 2E1 over previous 5 days
- •No allergy to APAP or fomepizole
- •BMI < 29
排除标准
- •Pregnant or lactating
- •History of alcohol abuse
- •Allergy to APAP or fomepizole
- •Screening LFTs above normal range
研究组 & 干预措施
A
Experimental
Oral APAP and IV Fomepizole.
干预措施: Fomepizole (Drug)
A
Experimental
Oral APAP and IV Fomepizole.
干预措施: APAP (Drug)
B
Active Comparator
Oral APAP.
干预措施: APAP (Drug)
结局指标
主要结局
Oxidative metabolism of APAP
时间窗: 24 hours
Measurement of oxidized metabolites of APAP
次要结局
未报告次要终点
研究者
研究点 (1)
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