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

NCT05418803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-06-16

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

YHP1807 Tab. 2.5mg

Rivaroxaban 2.5mg

DRUG

YHR1901 Tab. 2.5mg

Rivaroxaban 2.5mg

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

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 NCT05418803 on ClinicalTrials.gov