Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
Verified
Porto, Portugal
Not recruiting
Bioequivalence Study of Apixaban 5 mg Film‑Coated Tablets in Healthy Volunteers Under Fasting Conditions
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
The study looks at a blood‑clot‑preventing medicine. The test product is a tablet containing apixaban 5 mg, compared with the marketed tablet called Eliquis. The aim is to show that the two tablets work in the same way (bioequivalence). Healthy volunteers without any medical condition will take the tablets while fasting.
Each participant will receive one tablet of each type, with a wash‑out period in between, and the order will be chosen at random. Blood samples will be taken to measure how much medicine reaches the bloodstream and how quickly. The highest level reached in the blood is called Cmax, and the overall exposure over time is measured as AUC0-t. Other numbers that will be looked at include the time to reach the highest level (tmax), the total exposure until the drug is gone (AUC0-∞), the portion of exposure that must be estimated (%AUCextrap), the rate at which the drug leaves the body (λz), and the half‑life, or the time it takes for the amount in the blood to fall by half (t½). Any unwanted effects that appear after taking the tablet will be recorded as treatment emergent adverse events (TEAEs). The study lasts for two separate dosing periods and finishes after the final follow‑up visit.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Free written informed consent must be signed before any study procedures. This is a document that shows you understand the study and agree to take part.
- Negative test results are required for HIV (anti‑HIV‑1Ab and anti‑HIV‑2Ab), Hepatitis B (HBsAg), and Hepatitis C (anti‑HCVAb). These are blood tests that check for infections.
- You must be a non‑smoker or have not used tobacco or nicotine products for at least 6 months (180 days) before the screening visit.
- If you are female, you must either be unable to become pregnant (non‑childbearing potential) or, if you could become pregnant, you must agree to use an accepted contraceptive method from at least 4 weeks before the first study visit until the study ends.
- You must be willing to follow all study procedures and any restrictions.
- Your age must be between 18 and 55 years at the time you sign the consent.
- Your body mass index (BMI) must be between 18.5 and 30.0 kg/m². BMI is a simple calculation that relates your weight to your height.
- You must have no clinically relevant diseases in your medical history.
- You must have no clinically relevant abnormalities found during the physical examination.
- Your vital signs (such as blood pressure, heart rate, and temperature) must be normal.
- Your 12‑lead ECG must be normal. This test records the electrical activity of your heart.
- Your clinical laboratory tests (blood and urine tests) must be normal.
Who cannot join the trial?
31 criteria
- Known hypersensitivity (allergic reaction) to the study drug or any of its inactive ingredients (excipients).
- Any wound or condition that could cause serious bleeding, as judged by the doctor.
- Blood test showing liver enzymes ALT or AST higher than the normal range (these enzymes indicate liver health).
- Kidney function test showing creatinine clearance below normal, measured using the Cockcroft‑Gault formula (a method to estimate kidney filtering ability).
- Positive test for illegal drugs or alcohol (ethanol).
- Received a long‑acting injection or implant of any medication (except birth‑control shots) in the past 6 months.
- Drinking more than 14 alcoholic drinks per week for men or more than 7 per week for women in the past 6 months.
- Consuming coffee, tea, cola, chocolate, or other foods with more than about 500 mg of caffeine‑like substances (methylxanthines) each day for the past 6 months.
- Participated in any other clinical trial in the past 2 months.
- Participated in more than two clinical trials in the past year.
- Donated blood or lost at least 450 mL of blood, or had plasma exchange (plasmapheresis) in the past 2 months.
- Known severe allergic reaction to any other medication.
- Difficulty fasting or having dietary restrictions (e.g., lactose intolerance, vegan, low‑fat, low‑sodium) that would interfere with the study meals.
- Veins in both arms that are not suitable for an intravenous (IV) line (veins unsuitable for intravenous puncture).
- Difficulty swallowing pills or capsules.
- For women who could become pregnant, a positive pregnancy test.
- Breast‑feeding women.
- Any other health problem that the doctor thinks makes participation unsafe.
- Any recent illness, condition, or treatment that could increase risk or affect how the drug works in the body (pharmacokinetics).
- Use of prescription or over‑the‑counter medicines, vitamins, supplements, minerals, or herbal products within 4 weeks before the study, unless the doctor decides they are safe.
- Use of medicines that are toxic to the liver or that change liver metabolism within 90 days before the study, unless the doctor decides they are safe (liver‑toxic drug, systemic drug).
- Eating pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit (fresh, canned, or frozen) within the past week.
- Having any gastrointestinal, kidney, or liver disease (e.g., ulcer, inflammatory bowel disease, pancreatitis) or past surgery (e.g., gallbladder removal, stomach surgery) that could affect drug absorption or safety.
- Chewing gum within the past 48 hours.
- Doing intense exercise within the past 48 hours.
- History of drug or alcohol abuse.
- Known inherited conditions that affect sugar digestion (e.g., hereditary galactose intolerance, total lactase deficiency, or glucose‑galactose malabsorption).
- History of a serious bleeding event (e.g., bleeding in the brain, spine, eye, abdomen, joints, or a drop in hemoglobin of 2 g/dL or more, or need for a blood transfusion of 2 units or more).
- History of blood‑clotting disorders (e.g., hemophilia, von Willebrand disease, clotting factor deficiencies, tendency to form clots, or deep vein thrombosis).
- History of liver disease that causes problems with blood clotting and bleeding risk.
- Currently having active, clinically important bleeding.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Apixaban
is an oral medication that helps prevent blood clots from forming. In this study, participants took a tablet of Apixaban under fasting conditions so researchers could measure how much of the drug entered the bloodstream. The goal was to see if this version of the medication works the same way as a known reference product.
Eliquis
is a brand-name version of the same blood‑clot‑preventing medicine. In the trial, participants also took Eliquis tablets under the same conditions. By comparing the blood levels of Eliquis with those of the test product, researchers aimed to confirm that the two medicines are bioequivalent, meaning they deliver the same amount of active ingredient to the body.
What is already known about the treatment
Apixaban 5 mg film-coated tablets
It is taken by mouth as a film‑coated tablet. Apixaban is an approved medicine and is well described in medical literature as a blood‑thinner. It is mainly used to prevent clots that can cause stroke in atrial fibrillation and to treat or prevent deep‑vein thrombosis and pulmonary embolism. It works by directly blocking a protein called factor Xa, which stops the final steps of clot formation, and it belongs to the class of direct oral anticoagulants.
Eliquis 5 mg film-coated tablets
Eliquis is taken orally as a film‑coated tablet. Eliquis is a commercially available, widely studied anticoagulant that has been approved for many years. It is used to lower the risk of stroke in people with atrial fibrillation and to treat or prevent deep‑vein thrombosis and pulmonary embolism. It blocks the same factor Xa protein to stop clotting and is classified as a direct oral anticoagulant.
Investigated diseases
(no output)
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506844-18-00Protocol codeCFA-1028-2-23Estimated enrolment24 patientsSponsorLaboratorios Cinfa S.A.
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?