Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution

• Status: Terminated
• Trial end date: 2009-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shire
• Treatments: Adderall; Dextroamphetamine; Lisdexamfetamine Dimesylate; Pharmaceutical Solutions

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