Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution
Condition: Healthy
Intervention: Lisdexamfetamine Dimesylate; Racemic mixture of dextroamphetamine and lisdexamfetamine
Intervention description: 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.; 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.
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Dextroamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Not required

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
    

Eligibility criteria:

        Inclusion Criteria

          -  Healthy young adults, male or female (non-pregnant and non-lactating), age 18-25 years
             at time of consent

          -  Have a body mass index (BMI) between 20.0 and 29.0kg/m2

          -  Satisfactory medical assessment with no clinically significant or relevant

          -  Subject must demonstrate a positive response to amphetamine at Screening

        Exclusion Criteria

          -  A history of current or recurrent disease that could have an effect on the study

          -  Subject has a history of seizures, any tic disorder, or a current diagnosis and/or a
             known family history of Tourette's Disorder

          -  Subject has a concurrent chronic or acute illness or other condition that might
             confound the results of safety assessments or that might increase risk to the subject

          -  Subject has any clinically significant ECG and/or laboratory abnormalities

          -  Subject has a documented allergy, hypersensitivity or intolerance to amphetamines

          -  Subject has been prescribed or has taken amphetamine products in the past, including
             childhood; recreational use may not be exclusionary per the Investigator's discretion

          -  Subject has a known family history of sudden cardiac death or ventricular arrhythmia

          -  Subject has a recent history (within the past 6 months) of suspected substance abuse
             or dependence disorder (excluding nicotine)

          -  Subject has participated in any investigational clinical or vaccine trial within 30
             days prior to the first dose of study drug

          -  Subjects is currently considered a suicide risk, has previously made a suicide attempt
             or has a prior history of, or is currently demonstrating suicidal ideation