Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-26 @ 10:32 AM
Study NCT ID:
NCT02537405
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2015-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects
Status:
COMPLETED
Status Verified Date:
2015-08
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:
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.
Detailed Description:
None
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?: