Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02402595
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2015-02-26
Brief Title:
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
Sponsor:
Avanir Pharmaceuticals
Organization:
Avanir Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Single-center Randomized Double-blind Double-dummy Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2017-03
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:
DDI
Brief Summary:
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor itraconazole on the steady-state PK of AVP-923 and AVP-786
Detailed Description:
A Phase 1 single-center randomized double-blind double-dummy drug interaction study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None