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临床试验/NCT02184104
NCT02184104已完成不适用

Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device

University of Tennessee2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Caffeine plasma concentration

研究概览

简要总结

The purpose of this study is to determine how fast caffeine gets into your body with a product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your blood. You will also be asked to fill out some scales to measure the effects you feel after the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster than after an energy drink.

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
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteer
  • non-smoker

排除标准

  • Take chronic medication
  • Co-existing diseases
  • Platelet count less than 100,000/uL (per microliter)
  • Acute or chronic psychiatric condition
  • Consume more than 300 mg of caffeine per day
  • Participated in another study within last 30 days or donated blood in last 6 weeks

研究组 & 干预措施

Aeroshot

Active Comparator

A single 100 mg caffeine dose administered using the Aeroshot device.

干预措施: Caffeine (Dietary Supplement)

Energy Drink

Active Comparator

A single 100 mg caffeine dose administered as an oral solution.

干预措施: Caffeine (Dietary Supplement)

结局指标

主要结局

Caffeine plasma concentration

时间窗: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours

These are the collection times of blood samples relative to when the caffeine dose was consumed.

次要结局

  • Caffeine effects(0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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