At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 42 enrolled

Drug / intervention

SPD503 +2 moredrug

Likely dose

SPD503 4mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00919867

NCT00919867Phase 1Completed

Compare CT.gov

A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and VYVANSE, Administered Alone and in Combination in Healthy Adult Volunteers

Shire·interventional·Posted Jun 12, 2009·Updated Jun 14, 2021

In Brief

A Phase 1 clinical trial evaluating SPD503, VYVANSE, and 1 other intervention for Healthy. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

First PostedJun 2009

Enrollment StartJun 2009

Primary CompletionJul 2009

TodayJul 2026

First PostedJun 12, 2009

Enrollment StartJun 24, 2009

Primary CompletionJul 30, 2009

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 17.1 years ago

Interventions

SPD503drug

SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

VYVANSEdrug

VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

SPD503 and VYVANSEdrug

SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.