Overview

Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions

Status:
Not yet recruiting

Trial end date:
2021-03-01

Target enrollment:

Participant gender:

Summary

This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test (Rivaroxaban, 10 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborator:

ClinPharmInvest, LLC

Treatments:

Rivaroxaban