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AzTrials

Antithrombic DrugPhase 1NCT06043297

Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects

A Phase 1 study testing Apixaban 5MG and Eliquis 5 mg in people with Antithrombic Drug, run by Humanis Saglık Anonim Sirketi at 1 site in India.

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

To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under fasting condition and to assess the bioequivalence. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Antithrombic Drug
What is being tested?
Apixaban 5MG and Eliquis 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIndia
Study dates
23 Feb 2023to 27 Apr 2023
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoker, normal, healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).
  • Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in m2 and body weight ≥ 60 kg.
  • Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (posterior-anterior view).
  • aPTT and PT within normal range.
  • Able to understand and comply with the study procedures, in the opinion of the investigator.
  • Able to give voluntary written informed consent for participation in the trial.
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  • In case of female subjects:
  • Surgically sterilized at least 6 months prior to study participation.
  • If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
  • And -Serum pregnancy test must be negative.

Who cannot join

  • Known hypersensitivity to Apixaban or any excipients or any related drug or any substance.
  • History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
  • Ingestion of medicine [prescribed \& over the counter (OTC) medication including herbal remedies, anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs) or serotoninnorepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory medicinal products (NSAIDs) including acetylsalicylic acid, inhibitors of both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp), such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole)and HIV protease inhibitors (e.g., ritonavir) and Inducers of CYP3A4 and P-gp (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) and any vaccine (including COVID-19 vaccine)] at any time within 14 days prior to dosing of Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
  • Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
  • CrCl value < 50 mL/min
  • Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
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  • A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.), or consumption of alcohol or alcoholic product within 48 hours prior to receiving study medicine of Period-I.
  • Smokers or who have smoked within last 06 months prior to start of the study.
  • The presence of clinically significant abnormal laboratory values during screening.
  • Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
  • History or presence of seizure or psychiatric disorders.
  • A history of difficulty with donating blood.
  • Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
  • Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
  • If investigational medicinal product is received within 90 days where there is no blood loss except safety laboratory testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
  • A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
  • A positive test result for HIV antibody (1 \&/or 2).
  • Consumption of grapefruit or grape fruit products within 72 hours prior to dosing of Period-I.
  • Difficulty in swallowing tablets or other oral solid dosage forms.
  • An unusual diet, for whatever reason (e.g., fasting, high potassium or low-sodium), for four weeks prior to receiving the study medicine in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
  • Nursing mothers (for female subjects).

Trial locations and contacts

1 site in 1 country.

India1 site

  • Lambda Therapeutic Research Ltd.

    Ahmedabad, Gujarat, 382481

Other trials in India

About this study

Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under fasting condition and to assess the bioequivalence.

Being tested
Apixaban 5MG, Eliquis 5 mg

What participants receive

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

  • Apixaban 5MGDrug

    Each film-coated tablet contains 5 mg apixaban

  • Eliquis 5 mgDrug

    Each film-coated tablet contains 5 mg apixaban

Study groups in NCT06043297
Study groupRoleWhat they receive
Apixaban 5 mg Film TabletsExperimentalNot described
Receives: Drug: Apixaban 5MG
Eliquis 5 mg Film tabletsActive comparatorNot described
Receives: Drug: Eliquis 5 mg

What is being measured

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

  1. Cmax

    Measured: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 hours

  2. AUC0-t

    Measured: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 hours

Secondary outcomes (1)

  1. AUC0-∞

    Measured: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 hours

Timeline

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

  1. First posted21 Sep 2023
  2. Study start23 Feb 2023
  3. Primary completion6 Mar 2023
  4. Study completion27 Apr 2023

Resources

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
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06043297
Sponsor's protocol ID
0335-21
Status last verified
Dec 2023
First submitted
4 Sep 2023
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apixaban 5MG and Eliquis 5 mg in people with Antithrombic Drug, run by Humanis Saglık Anonim Sirketi at 1 site in India.

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 10 inclusion and 21 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 15 Sep 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 India. 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?

Cmax (time frame: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.333, 4.667, 5.000, 5.500, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000, 48.000 and 72.000 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 NCT06043297.

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 15 Sep 2025.

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