NCT04511611View on ClinicalTrials.gov

Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 24, 2019

Primary Completion Date

March 27, 2019

Study Completion Date

May 13, 2019

Conditions
Clinical Pharmacology
Interventions
DRUG

Rivaroxaban (BAY 59-7939, Xarelto) in ODT form

10 mg as 1 x 10 mg orally disintegrating tablet (ODT)

DRUG

Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form

10 mg as 1 x 10 mg film-coated tablet

Trial Locations (3)

130-0004

Sumida Hospital, Sumida-ku

813-0017

Fukuoka Mirai Hospital, Fukuoka

861-4157

Medical Co. LTA Nishikumamoto hospital, Kumamoto

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY

NCT04511611 - Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects | Biotech Hunter | Biotech Hunter