Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 11:57 AM
Study NCT ID:
NCT00919867
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2009-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Sponsor:
Shire
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: