Conditions: Healthy
Keywords: Not required
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 3
Healthy volunteers: yes

Brief summary:
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

Detailed description:
Not required

Arms:
arm 1: 50mg capsule that has been emptied and made into solution arm 2: 20mg capsule that has been emptied, crushed, and made into solution

Interventions: intervention 1: Lisdexamfetamine Dimesylate intervention 2: Racemic mixture of dextroamphetamine and lisdexamfetamine
Intervention descriptions: intervention 1: Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit. intervention 2: Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.

Protocol document: