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 10 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases 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 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
80
10 mg as 1 x 10 mg orally disintegrating tablet (ODT)
10 mg as 1 x 10 mg film-coated tablet
Sumida Hospital
Sumida-ku, Tokyo, Japan
Fukuoka Mirai Hospital
Fukuoka, Japan
Medical Co. LTA Nishikumamoto hospital
Kumamoto, Japan
Cmax for plasma rivaroxaban concentration
Maximum observed concentration
Time frame: Up to 48 hours after study medication
AUC(0-tlast) for plasma rivaroxaban concentration
Area under the concentration versus time curve from time 0 to the last data point \> lower limit of quantitation
Time frame: Up to 48 hours after study medication
Number of subjects with treatment-emergent adverse events
Time frame: Up to 30 days after study medication
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