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

Shire

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine

Drug: Lisdexamfetamine Dimesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00776555

SPD489-112

Details and patient eligibility

About

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

Full description

Not required

Enrollment

3 patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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