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Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets

NCT06558058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-16

No results posted yet for this study

Summary

This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fasting conditions which included 28 healthy adult male and female subjects. The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 10 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 10 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fasting condition in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Rivaroxaban 10 mg film-coated tablet

One tablet of the test drug was given orally after an overnight fast.

DRUG

Xarelto 10 mg film-coated tablet

One tablet of the reference drug was given orally after an overnight fast.

Sponsors & Collaborators

  • PT Equilab International

    collaborator INDUSTRY

  • Dexa Medica Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2023-06-16
Completion
2023-08-29

Countries

  • Indonesia

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 NCT06558058 on ClinicalTrials.gov