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

NCT04753489 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-02-15

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Rivaroxaban film-coated tablet 10 mg

Rivaroxaban is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of rivaroxaban.

DRUG

Xarelto® film-coated tablet 10 mg

Xarelto® is manufactured by Bayer AG, Germany. Each tablet contains 10 mg of rivaroxaban.

Sponsors & Collaborators

  • ClinPharmInvest, LLC

    collaborator OTHER

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Alexander Khokhlov · ClinPharmInvest, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-13
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753489 on ClinicalTrials.gov