Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets

NCT06558058 | Completed Phase 1

• 1 other identifier: BE. 786/EQL/2023
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• AUC(0-t)

  Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t

  36 hours

• Cmax

  Maximum plasma concentration

  36 hours

Secondary Outcomes (3)

• AUC(0-inf)

  36 hours

• T1/2

  36 hours

• Tmax

  36 hours

Study Arms (2)

Test Rivaroxaban 10 mg PT Dexa Medica

EXPERIMENTAL

Rivaroxaban 10 mg Film-coated Tablet, produced by PT Dexa Medica, Indonesia

Drug: Rivaroxaban 10 mg film-coated tablet

Reference Xarelto 10 mg Bayer

ACTIVE COMPARATOR

Xarelto 10 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia

Drug: Xarelto 10 mg film-coated tablet

Interventions

Rivaroxaban 10 mg film-coated tablet DRUG

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

Test Rivaroxaban 10 mg PT Dexa Medica

Xarelto 10 mg film-coated tablet DRUG

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

Reference Xarelto 10 mg Bayer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
• Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
• Aged 18 - 55 years inclusive.
• Non-smokers.
• Body mass index within 18 to 25 kg/m2.
• Vital signs (after 10 minutes rest) must be within the following ranges:
• Systolic blood pressure: 100 - 129 mmHg
• Diastolic blood pressure: 60 - 84 mmHg
• Pulse rate: 60 - 90 bpm.
• Willing to practice abstention or contraception during the study.
• Prothrombin time (PT) and activated partial thromboplastin time (aPTT) values should be within normal range.
• Normal renal function with acceptable creatinine clearance (CrCl) \>50 mL/min.

You may not qualify if:

• History of allergy or hypersensitivity or contraindication to rivaroxaban or factor Xa inhibitors or allied drugs.
• Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
• Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
• Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
• Patient with significant liver disease (severe hepatic impairment/Child Pugh C).
• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Positive result for COVID-19 rapid antigen test (this criteria only applied if the study conduct during pandemic condition).
• Clinically significant hematology abnormalities.
• Clinically significant electrocardiogram (ECG) abnormalities.
• Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
• Past history of anaphylaxis or angioedema.
• History of drug or alcohol abuse within 12 months prior to screening for this study.
• Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
• History of any bleeding or coagulative disorders.
• History of significant head or spinal cord injury or recent surgery on the brain, spinal cord or eyes.

Sponsors & Collaborators

• Dexa Medica Group: lead
• PT Equilab International: collaborator

Study Sites (1)

PT Equilab International

Jakarta, 12430, Indonesia

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a bioequivalence study.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: June 8, 2023
• Primary Completion: June 16, 2023
• Study Completion: August 29, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

ID (1)