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Bioequivalence Study of Apixaban 5 mg Film‑Coated Tablets in Healthy Volunteers Under Fasting Conditions

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What is this study about?

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.

1 randomization and sequence assignment

after joining the study, you will be randomly assigned to one of two possible sequences. the sequence determines whether you receive the test product first and the comparator later, or the opposite.

2 first dosing period

you will take a single oral dose of 5 mg of a film‑coated tablet. the tablet may be the test product (apixaban 5 mg) or the comparator product (eliquis 5 mg), depending on your assigned sequence.

the dose must be taken after an overnight fast (no food for at least 10 hours). you should not eat or drink anything except water for at least 4 hours after taking the tablet.

3 blood sampling and safety monitoring after the first dose

blood samples will be collected at several time points during the next few hours to measure the level of apixaban in your blood.

your vital signs (such as blood pressure and heart rate) and any symptoms will be monitored to identify possible side effects.

4 washout period

after the first dosing period, a washout period will be observed. this interval allows the drug to leave your body before the next dose is taken. the exact length of the washout period will be determined by the study protocol, typically several days.

5 second dosing period

you will take a single oral dose of the other 5 mg tablet (the product you did not receive in the first period). the same fasting conditions apply: take the tablet after an overnight fast and avoid food for at least 4 hours afterward.

6 blood sampling and safety monitoring after the second dose

blood samples will again be collected at multiple time points to assess the concentration of apixaban after the second dose.

your vital signs and any adverse symptoms will continue to be monitored.

7 study completion

after the final assessments, the study will be considered complete for you. the data collected will be used to compare the test product with the comparator product.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Bkvwqejanchc Irsprkhvuerp E Dyijpiuwkcszrsn Em Sqfax Ling Porto Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not recruiting
26.12.2023

Trial locations

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.

Trial ID:
2023-506844-18-00
Protocol code:
CFA-1028-2-23
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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