NCT01433952已完成1 期
Pharmacokinetics of High Dose Oral Thiamine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC) for whole blood
研究概览
简要总结
Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.
The aims of this study are to:
- Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers;
- Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age between 18 and 55
排除标准
- •Non dietary thiamine supplement within two weeks of the start of the study or during the study
- •History of thiamine deficiency
- •Anemia (Hgb<10)
- •History of gastrointestinal absorption disorders
- •Taking prescription or over-the-counter medication
- •Pregnant or breast feeding a child
- •Alcohol and or drug abuse
结局指标
主要结局
Area Under the Curve (AUC) for whole blood
时间窗: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
Area Under the Curve (AUC) for plasma
时间窗: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (2)
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