Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet

NCT06817811 | Completed Phase 1

• 1 other identifier: BE. 644/EQL/2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects. The objective of this study was to find out whether the bioavailability of apixaban 5 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Eliquis® 5 mg filmcoated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia).

Conditions

Health

Outcome Measures

Primary Outcomes (2)

• AUC(0-t)

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

  48 hours

• Cmax

  Maximum plasma concentration

  48 hours

Secondary Outcomes (3)

• AUC(0-inf)

  48 hours

• T1/2

  48 hours

• Tmax

  48 hours

Study Arms (2)

Test Apixaban 5 mg Film-Coated Tablet PT Dexa Medica

EXPERIMENTAL

Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)

Drug: Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)

Reference Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb

ACTIVE COMPARATOR

Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia

Drug: Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)

Interventions

Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica) DRUG

One tablet of the test drug was given orally under fasting condition

Test Apixaban 5 mg Film-Coated Tablet PT Dexa Medica

Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia) DRUG

One tablet of the reference drug was given orally under fasting condition

Reference Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb

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.
• Preferably non-smokers or smoke less than 10 cigarettes per day.
• Body mass index within 18 to 25 kg/m2.
• Normal prothrombin time (PT) and normal partial thromboplastin time (aPTT)
• Creatinine clearance \> 50 mL/min
• 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.

You may not qualify if:

• History of allergy or hypersensitivity or contraindication to apixaban or factor Xa inhibitors or allied drug.
• 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.
• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Clinically significant hematology abnormalities.
• Positive result for COVID-19 antigen rapid test.
• 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 injury within the last two years.
• Presence of difficulty in accessibility of veins in left or right arm.

Sponsors & Collaborators

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

Study Sites (1)

PT Equilab International

Jakarta, Indonesia

Location

MeSH Terms

Interventions

apixaban; Product Packaging

Intervention Hierarchy (Ancestors)

Industry; Technology, Industry, and Agriculture

Study Officials

• Danang A Yunaidi

  PT Equilab International

  PRINCIPAL INVESTIGATOR

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: February 5, 2025
• First Posted: February 10, 2025
• Study Start: April 15, 2021
• Primary Completion: April 24, 2021
• Study Completion: June 3, 2021
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

ID (1)