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

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 21, 2019

Primary Completion Date

March 7, 2019

Study Completion Date

April 12, 2019

Conditions
Clinical Pharmacology
Interventions
DRUG

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

15 mg as 1 x 15 mg orally disintegrating tablet (ODT)

DRUG

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

15 mg as 1 x 15 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

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY