BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects

Phase 1 Completed 34 enrolled Yuhan Corporation

RandomizedCrossoverOpen-labelTreatment

Summary

The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.

Timeline

Start: 2020-01-28
Primary completion: 2020-02-14
Completion: 2020-02-14

Publications

Moon SJ, Kim Y, Kim SY, Jeon JY, Song E, Lim Y, Kim MG. Comparative pharmacokinetics of two formulations of 2.5-mg rivaroxaban in healthy Korean subjects. Int J Clin Pharmacol Ther. 2023 Mar 5. doi: 10.5414/CP204335. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rivaroxaban	Other / unclassified	2.5 mg	Oral

Indications

No indication recorded.