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临床试验/NCT01765933
NCT01765933已完成不适用

Pharmacokinetic and Physiological Effects of Oral DMAA Administration

University of Memphis2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
pharmacokinetics

研究概览

简要总结

1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary supplements. It is also used within "party pills," often in conjunction with alcohol and other drugs, and has been associated with untoward effects when abused at high dosages. To our knowledge, no studies have been conducted to determine the combined pharmacokinetic profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based solely on case reports would be problematic, in particular when accepting testimony from patients in uncontrolled environment, potentially under the influence of alcohol and other drugs. This is especially true in light of the fact that no prospective studies have shown these effects. Hence, the intent of the present study was to determine the pharmacokinetic profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This represents a typical dosage within one serving of many popular dietary supplements containing DMAA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • must be able to swallow pill

排除标准

  • self-reported cardiovascular or metabolic problems
  • current smokers

结局指标

主要结局

pharmacokinetics

时间窗: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr

The area under the plasma concentration-time curve from time 0 to infinity was calculated using the trapezoidal rule extrapolated to time infinity. The terminal half-life (t 1/2) was calculated using 0.693/Lambda z, with Lambda z as the terminal rate elimination constant. Peak concentration (Cmax), lag time (tlag), time of maximum concentration (tmax), apparent volume of distribution during the terminal elimination phase (Vz/F), and oral clearance (CL/F) were also calculated.

次要结局

  • physiological effects on heart rate and blood pressure(0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Schilling

Associate Professor

University of Memphis

研究点 (2)

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