Expired Study
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Boston, Massachusetts 02114


Purpose:

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


Study summary:

Not required


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


NCT ID:

NCT00776555


Primary Contact:

Principal Investigator
Thomas Spencer, M.D.
Massachusetts General Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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