Status:
COMPLETED
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
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Clinical Pharmacology
Eligibility:
MALE
20-40 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m²
Exclusion
- Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
- Subject with known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Subject with known coagulation disorders (e.g. von Willebrand disease, hemophilia)
- Subject with febrile illness within 1 week before the first study drug administration
- Subject with suspicion of drug or alcohol abuse
- Subject with intake of foods or beverages containing grapefruit, pomelo, Seville orange, and tangelo within 1 week before the first study drug administration
- Subject with therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment
- Subject with clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the corrected QT (QTc) interval over 450 msec
- Subject with systolic blood pressure below 90 or above 130 mmHg
- Subject with diastolic blood pressure below 45 or above 85 mmHg
- Subject with clinically relevant deviations of the screened laboratory parameters from reference ranges
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04511637
Start Date
January 21 2019
End Date
April 12 2019
Last Update
August 13 2020
Active Locations (3)
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1
Sumida Hospital
Sumida-ku, Tokyo, Japan, 130-0004
2
Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
3
Medical Co. LTA Nishikumamoto hospital
Kumamoto, Japan, 861-4157