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

PHASE1TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

November 21, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Healthy
Interventions
DRUG

Lisdexamfetamine Dimesylate

Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit.

DRUG

Racemic mixture of dextroamphetamine and lisdexamfetamine

Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY