日本人成人男性を対象に、10mg投与時のリバーロキサバン（ザレルト）製剤（口腔内崩壊錠とフィルムコーティング錠）の生物学的同等性への影響を比較する研究

基本情報

NCT ID

NCT04511611

ステータス

完了

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

80

治験依頼者名

Bayer

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)