HealthPhase 1NCT06817811

Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet

A Phase 1 study testing Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica) and 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) in people with Health, run by Dexa Medica Group at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Health
What is being tested?: Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica) and 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)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteIndonesia
Study dates: 15 Apr 2021to 3 Jun 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

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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.

Who cannot join

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.

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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.
A donation or significant blood loss within 90 days before this study's first dosing day.
Intake of any prescription, (especially apixaban, other anticoagulants, azole antimycotics), non-prescription drug, (including hormonal contraception), food supplements or herbal medicines within 21 days of this study's first dosing day

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

PT Equilab International
Jakarta

Other trials in Indonesia

About this study

Official title: Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator 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)

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).

Read the detailed description

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). 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 participating subjects were required to have an 8 hours overnight fast and in the next morning (first day of period) were given orally the test drug (apixaban 5 mg film-coated tablet produced by PT Dexa Medica) or the comparator 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) with 200 mL of water. The subject's oral cavity was checked thoroughly to confirm complete medication and fluid consumption after dosing. Blood samples were drawn before taking the drug (control), and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 9.00, 12.00, 24.00, 36.00, and 48.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of apixaban following single dose administration. The plasma concentrations of apixaban were determined by using a validated ultra-performance liquid chromatography with tandem mass spectrometry detection (UPLC-MS/MS).

Conditions: Health
Being tested: Apixaban 5 mg Film-Coated Tablet (produced by 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)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)Drug
One tablet of the test drug was given orally under fasting condition
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

Study groups in NCT06817811
Study group	Role	What they receive
Test Apixaban 5 mg Film-Coated Tablet PT Dexa Medica	Experimental	Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica) Receives: 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 Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(0-t)
Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t
Measured: 48 hours
Cmax
Maximum plasma concentration
Measured: 48 hours

Secondary outcomes (3)

AUC(0-inf)
Area under the plasma concentration-time curve extrapolated to infinitive time
Measured: 48 hours
T1/2
Plasma half-life
Measured: 48 hours
Tmax
Time taken to reach maximum observed plasma concentration
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 20213 Jun 2021

First posted10 Feb 2025
Study start15 Apr 2021
Primary completion24 Apr 2021
Study completion3 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: This was a bioequivalence study
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06817811
Sponsor's protocol ID: BE. 644/EQL/2020
Status last verified: Feb 2025
First submitted: 5 Feb 2025
Last updated: 10 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator 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)
ClinicalTrials.gov ID: NCT06817811
Acronym / sponsor ID: BE. 644/EQL/2020
Conditions: Health
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Dexa Medica GroupIndustry (pharma, biotech, devices)
Collaborators: PT Equilab International
Study start: 15 Apr 2021 (actual)
Primary completion: 24 Apr 2021 (actual)
Study completion: 3 Jun 2021 (actual)
First posted: 10 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This was a bioequivalence study

Arm	Type	Receives
Test Apixaban 5 mg Film-Coated Tablet PT Dexa Medica	Experimental	Drug: Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)
Reference Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb	Active comparator	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)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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)One tablet of the test drug was given orally under fasting condition	Drug	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)One tablet of the reference drug was given orally under fasting condition	Drug	Reference Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb

Primary outcome

AUC(0-t)
Time frame: 48 hours
Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t
Cmax
Time frame: 48 hours
Maximum plasma concentration

3 secondary outcomes

AUC(0-inf)
Time frame: 48 hours
T1/2
Time frame: 48 hours
Tmax
Time frame: 48 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Danang A Yunaidi principal investigator

PT Equilab International

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-t) (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.