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Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions

NCT04689919 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-09-07

No results posted yet for this study

Summary

A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days. Blood samples will be taken up to 48hours post-dose.

Conditions

  • Bioequivalence

Interventions

DRUG

Rivaroxaban 20 MG Oral Tablet

The subjects randomly received single oral dose of Rivaroxaban 20 MG Tablet.

Sponsors & Collaborators

  • The Searle Company Limited Pakistan

    collaborator INDUSTRY

  • Center for Bioequivalence Studies and Clinical Research (CBSCR), HEJ Research Institute of chemistry, University of Karachi

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Muhammad Raza Shah, PhD · CBSCR , ICCBS, University of Karachi

  • Naghma Hashmi (Co-PI), PhD · CBSCR, ICCBS, University of Karachi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-02-19
Primary Completion
2022-03-07
Completion
2022-04-05

Countries

  • Pakistan

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 NCT04689919 on ClinicalTrials.gov