Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753489
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-02-10
Brief Title:
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions
Sponsor:
Pharmtechnology LLC
Organization:
Pharmtechnology LLC
Study Overview
Official Title:
Randomized Crossover 2-Period Single-dose BE Study of Rivaroxaban Film-coated Tablets 10mg Pharmtechnology LLC Republic of Belarus and Xarelto Film-coated Tablets 10mg Bayer AG Germany in Healthy Male Volunteers in Fasting Conditions
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
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 an open-labeled laboratory-blinded randomized two period single-center crossover comparative study where each participant will be randomly assigned to the reference Xarelto 10 mg film-coated tablets or the test Rivaroxaban 10 mg film-coated tablets formulation in each period of study sequences Test-Reference TR or Reference-Test RT in order to evaluate if both formulations are bioequivalent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None