NCT00776555

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

A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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

Detailed description

Not required

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-21
• Primary completion: 2009-03-31
• Completion: 2009-03-31
• First posted: 2008-10-21
• Last updated: 2021-06-09
• Results posted: 2010-07-07

Locations

1 site across 1 country: United States