Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 9:13 AM
Study NCT ID:
NCT02537457
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Rivaroxaban
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 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 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg 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?: