CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Lisdexamfetamine Dimesylatedrug
Likely dose
Lisdexamfetamine Dimesylate 70 mgfrom 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/NCT01890785
NCT01890785Phase 1Completed
CompareCT.gov

A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of SPD489 When the Contents Are Emptied Into a Soft Food and Orange Juice in Healthy Adult Subjects

Shire·interventional·Posted Jul 2, 2013·Updated Jun 3, 2021

In Brief

A Phase 1 clinical trial evaluating Lisdexamfetamine Dimesylate for Healthy Volunteers. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2, 2013
Enrollment StartJul 15, 2013
Primary CompletionAug 22, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13 years ago

Interventions

Lisdexamfetamine Dimesylatedrug

Single dose of a 70 mg capsule on Day 1