Status:
TERMINATED
Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution
Lead Sponsor:
Shire
Conditions:
Healthy
Eligibility:
All Genders
18-25 years
Phase:
PHASE1
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 administe...
Detailed Description
Not required
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00776555
Start Date
November 21 2008
End Date
March 31 2009
Last Update
June 9 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114