Clinical Trials Directory

Trials / Completed

CompletedNCT01890785

Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Shire · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGLisdexamfetamine DimesylateSingle dose of a 70 mg capsule on Day 1

Timeline

Start date
2013-07-15
Primary completion
2013-08-22
Completion
2013-08-22
First posted
2013-07-02
Last updated
2021-06-03
Results posted
2014-04-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01890785. Inclusion in this directory is not an endorsement.

Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers (NCT01890785) · Clinical Trials Directory