A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Drug Rating Questionnaire-Subject (DRQ-S), Question 2
研究概览
简要总结
The purpose of this study is to compare subjective drug liking using the Drug Rating Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and ADDERALL XR® when administered as an oral solution.
Hypothesis: DRQ-S, question 2 will show no difference between the two drugs
详细描述
Not required
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vyvanse™
50mg capsule that has been emptied and made into solution
干预措施: Lisdexamfetamine Dimesylate (Drug)
ADDERALL XR®
20mg capsule that has been emptied, crushed, and made into solution
干预措施: Racemic mixture of dextroamphetamine and lisdexamfetamine (Drug)
结局指标
主要结局
Drug Rating Questionnaire-Subject (DRQ-S), Question 2
时间窗: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose
Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
次要结局
- DRQ-S, Question 3(Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose)
- DRQ-S, Question 1(Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose)