Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-13 @ 7:50 AM
Study NCT ID:
NCT02596100
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Sponsor:
Portola Pharmaceuticals
Organization:
Study Overview
Official Title:
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Status:
COMPLETED
Status Verified Date:
2023-08
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:
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.
Detailed Description:
Serial blood samples will be obtained for PK evaluation.
Study Oversight
Has Oversight DMC:
False
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?: