Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511637
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2020-08-12
Brief Title:
Study to Compare the Effect of the Formulations Orally Disintegrating Tablet and Film-coated Tablet on the Bioequivalence of Drug Rivaroxaban Xarelto at Dose of 15 mg in Japanese Healthy Male Adult Subjects
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Randomized Non-blinded Two-way Crossover Study to Assess Bioequivalence Between a Rivaroxaban 15 mg Orally Disintegrating Tablet Administered With Water or Without Water and a Rivaroxaban 15 mg Film-coated Tablet in Japanese Healthy Male Adult Subjects
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Researchers in this study wanted to compare the effect of the formulation orally disintegrating tablet and film-coated tablet on the bioequivalence of drug Rivaroxaban brand name Xarelto at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years Rivaroxaban is an approved drug to be used for the prevention of eventsdiseases caused by blood clots Currently there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules To further improve patients convenience a new formulation orally disintegrating tablet ODT a drug dosage form designed to be dissolved on the tongue rather than swallowed whole is under development The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water
Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet There were at least 5 days between the two doses Observation for each participant lasted about 6 weeks in total Blood samples were collected from the participants to measure the blood level of the study drug
Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet There were at least 5 days between the two doses Observation for each participant lasted about 6 weeks in total Blood samples were collected from the participants to measure the blood level of the study drug
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