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Study comparing apixaban tablets to test if they work the same way in the body in healthy volunteers who have not eaten

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at thromboembolism, which is a condition where blood clots form and block blood vessels. The treatment being tested is apixaban, a medicine that helps prevent blood clots. In this study, two different versions of apixaban tablets will be compared: a test version and a reference version that is already available on the market. Both versions contain 5 mg of the active ingredient. The purpose of this study is to check if the test version of apixaban works in the body in the same way as the reference version that is already being used.

The study will involve healthy volunteers who will take a single dose of each version of the apixaban tablet on separate occasions. Between taking the two different versions, there will be a waiting period to make sure the first dose is completely cleared from the body before the second dose is given. The volunteers will not eat before taking the medicine to see how the body absorbs it under fasting conditions. This type of study design is called a crossover study because each person will receive both versions of the medicine at different times.

During the study, blood samples will be collected from the volunteers at different times after they take the medicine. These samples will be used to measure how much apixaban is in the blood and how long it stays there. The researchers will look at specific measurements to compare the two versions, including the highest amount of medicine in the blood and the total amount of medicine absorbed over time. This information will help determine if the test version works as well as the reference version.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial single dose administration
Your participation will take place in a crossover study, which means you will receive different treatments in separate periods.
You will receive a single dose of apixaban 5 mg tablet taken by mouth. Apixaban is a medication used to prevent blood clots.
The tablet will be administered while you are fasting, which means you will not have eaten for a period before taking the medication.
The medication will be given in the form of a film-coated tablet that you will swallow.
Step 2
Blood sample collection period
After taking the medication, blood samples will be collected from you at specific times to measure the amount of apixaban in your blood.
These samples will help determine how quickly and how much of the medication is absorbed by your body.
The measurements include AUC0-t (the total amount of medication in your blood over time), Cmax (the highest level of medication reached in your blood), and Tmax (the time it takes to reach the highest level).
Step 3
Washout period
After the first treatment period, there will be a washout period.
During this time, no medication will be given to you. This allows the apixaban from the first dose to be completely eliminated from your body before the next treatment period begins.
Step 4
Second single dose administration
After the washout period, you will receive a second single dose of apixaban 5 mg tablet.
This will be a different formulation of the medication compared to the first period. One will be a test formulation and the other will be a reference formulation.
The tablet will again be administered by mouth while you are fasting.
The order in which you receive the test or reference formulation will be determined randomly.
Step 5
Second blood sample collection period
Blood samples will be collected from you again at specific times after taking the second dose.
The same measurements will be performed to compare how your body absorbs and processes the different formulations of apixaban.
This comparison will help determine if the two formulations work in the same way in your body.
Step 6
Monitoring and safety assessments
Throughout your participation, your health will be monitored through physical examinations, vital signs (such as blood pressure and heart rate), and electrocardiogram (a test that records the electrical activity of your heart).
Laboratory tests will be performed, including blood tests to check your blood cells, clotting function, liver and kidney function, and urine tests.
Any side effects or changes in your health will be recorded during the study.

Who can join the trial?

8 criteria

You must be willing to participate in the study after receiving full information about its design, objectives, and possible risks, and you must provide written consent, which means signing a document agreeing to take part
You must be between 18 and 55 years old
You must be a male or female participant
You must not have any significant physical or mental health conditions that could affect the study
Your medical history, which is a record of your past health problems and treatments, and your physical examination, which is when a doctor checks your body, must show no significant abnormalities
Your blood tests must show no significant abnormalities, including tests for haematology (study of blood cells), coagulation (how well your blood clots), biochemistry (chemical processes in your body), serology (tests for infections like Hepatitis B, Hepatitis C, and HIV), and urinalysis (urine tests)
Your vital signs, which include blood pressure, heart rate, breathing rate, and body temperature, must show no significant abnormalities
Your electrocardiogram, which is a test that measures the electrical activity of your heart, must show no significant abnormalities

Who cannot join the trial?

4 criteria

The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
Without detailed exclusion criteria information, we cannot list the specific conditions or circumstances that would prevent participation in this study
Exclusion criteria typically include things like certain medical conditions, medications being taken, or other health factors that could affect the safety of participants or the results of the study
In this case, the trial information provided does not contain the necessary details about who should not participate

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Hospital Universitario De La Princesa
Madrid, Spain

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Investigated drugs

Apixaban is a blood-thinning medication that helps prevent blood clots from forming in your body. It works by blocking certain proteins in your blood that are responsible for clotting. This medication is commonly used to reduce the risk of stroke and dangerous blood clots in people with certain heart conditions or after certain surgeries. In this trial, researchers are comparing different tablet formulations of this medication to see if they work the same way in the body.

Apixaban

What is already known about the treatment

Apixaban – Apixaban is an oral medication available as film-coated tablets that is taken by mouth, typically used to prevent blood clots from forming in the body. It belongs to a class of drugs called anticoagulants, or blood thinners, and is widely approved and used in clinical practice for preventing thromboembolism, which occurs when blood clots block blood vessels and can lead to serious complications like stroke or pulmonary embolism. The medication works at the molecular level by directly blocking a specific protein in the blood called Factor Xa, which plays a key role in the blood clotting process, thereby reducing the blood's ability to form dangerous clots. This clinical trial is testing whether a new formulation of apixaban 5 mg tablets works in the body the same way as the currently available commercial version to ensure patients receive the same therapeutic benefit.

Investigated diseases

Thromboembolism – Thromboembolism is a condition where a blood clot forms in a blood vessel and then breaks loose to travel through the bloodstream. This traveling clot, called an embolus, can block blood flow when it gets stuck in a narrower vessel. The blockage prevents oxygen and nutrients from reaching tissues and organs beyond that point. Thromboembolism can occur in veins or arteries throughout the body. Common sites include the legs, lungs, brain, and heart. The condition develops when blood clots form due to slow blood flow, damage to blood vessel walls, or increased clotting tendency.