Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01786382
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2013-02-04
Brief Title:
A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole
Sponsor:
Presidio Pharmaceuticals Inc
Organization:
Presidio Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Potential Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole and Potentially Telaprevir in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2013-03
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:
None
Brief Summary:
The primary objectives of the study are to
Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic PK profile of midazolam following a single oral dose in human subjects
Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject
Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic PK profile of midazolam following a single oral dose in human subjects
Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject
Detailed Description:
None
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