Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
Condition: Healthy Volunteers
Intervention: Lisdexamfetamine Dimesylate; Adderall XR (mixed salts amphetamine)
Intervention description: 50mg capsule; 20mg capsule
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate; Adderall
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug; Interaction; Study

Summary:

      The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR
      with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how
      much of the drug is absorbed into the body.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy volunteers, age 18 to 45 inclusive at the time of consent.

          2. Male, or non-pregnant, non-lactating female

          3. Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG)
             pregnancy test at Screening, and a negative urine pregnancy test on Day -1 after
             checking into the clinic the day before the first dose of investigational product.

          4. Body Mass Index (BMI) between 20.0 and 30.0 kg/m² inclusive. This inclusion criterion
             will only be assessed at the first screening visit.

          5. Satisfactory medical assessment with no significant or relevant abnormality in medical
             history, physical examination (PE), vital signs and laboratory evaluation

          6. Normal or clinically insignificant Screening ECG findings as assessed by the
             Investigator.

          7. Ability to swallow investigational products.

        Exclusion Criteria:

          1. Current or recurrent disease that could affect the action, absorption or disposition
             of the investigational products, or could affect clinical or laboratory assessments.

          2. Current or relevant previous history of physical or psychiatric illness, any medical
             disorder that may require treatment or make the subject unlikely to fully comply with
             the requirements of the study or complete the study, or any condition that presents
             undue risk from the investigational products or study procedures.

          3. Significant illness, as judged by the Investigator, within 2 weeks of the first dose
             of investigational product.

          4. History of significant anxiety, tension or agitation as assessed by the Investigator.

          5. History of or current diagnosis of glaucoma.

          6. History of a seizure disorder (other than infantile febrile seizures), any tic
             disorder or a current diagnosis and/or known family history of Tourette's Disorder.

          7. History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural
             cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary
             artery disease, transient ischemic attack or stroke or other serious cardiac problems
             that may place them at increased vulnerability to the sympathomimetic effects of a
             stimulant drug.

          8. History of controlled or uncontrolled hypertension or a resting sitting systolic blood
             pressure >139mmHg or diastolic blood pressure >89mmHg.

          9. Known family history of sudden cardiac death or ventricular arrhythmia.

         10. Currently considered a suicide risk, has previously made a suicide attempt or has a
             prior history of, or is currently demonstrating suicidal ideation.

         11. Current use of any medication (including prescription, over the counter [OTC], herbal
             or homeopathic preparations) with the exception of hormonal replacement therapy or
             hormonal contraceptives (Current use is defined as use within 14 days of first dose of
             investigational product).

         12. Use of any medication known to inhibit or induce the CYP450 enzymes responsible for
             the metabolism of the investigational products within 14 days of first dose of
             investigational product.

         13. Known or suspected intolerance or hypersensitivity to the investigational product(s),
             closely related compounds or any of the stated ingredients.

         14. History of alcohol or other substance abuse within the last year.