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A study to compare the absorption of apixaban capsules and apixaban tablets in healthy volunteers to prevent thrombosis.

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What is this trial about?

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

This study focuses on thrombosis, which is a condition where a blood clot forms inside a blood vessel. The research involves comparing two different versions of the medication apixaban. One version is provided as Eliquis 5 mg film-coated tablets, while the other version is provided as apixaban 5 mg hard capsules. The goal of the study is to demonstrate the bioequivalence, meaning how the two different forms of the medicine perform similarly in the body, to ensure they work in the same way.

The study is conducted using a crossover design, which means participants receive both types of medication at different times during the trial. Participants will take a single oral dose, meaning the medicine is swallowed by mouth, while in a fasting state, which means not eating for a specific period before taking the medication. This process allows for a direct comparison of how the body absorbs the drug in its capsule form versus its tablet form.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial dose administration
A single dose of apixaban 5 mg is taken orally. this medication is provided either in a film-coated tablet form or as a hard capsule.
This dose is taken while fasting, which means no food should be consumed for a period before taking the medicine.
Step 2
Crossover period
Because this is a crossover study, a second period occurs where the other form of the medication is administered.
The second single dose of apixaban 5 mg is also taken orally under fasting conditions to compare how the different forms are absorbed by the body.

Who can join the trial?

6 criteria

Both men and women can participate if they provide written consent, which means they sign a document agreeing to join the study after being told about its goals, risks, and their right to stop at any time.
Participants must be between 18 and 55 years old.
People must not have any important organic conditions, which refers to physical problems with organs like the heart, lungs, or liver, or any psychic conditions, which are mental health issues.
Participants must not have any major health problems found during a physical examination, which is a routine check-up by a doctor.
There must be no serious issues found in haematology (the study of blood), coagulation (how your blood clots), biochemistry (the chemical processes in your body), serology (tests that look for antibodies or infections like Hepatitis B, Hepatitis C, or HIV), or urinalysis (a test of your urine).
Participants must have normal vital signs, which are measurements like blood pressure, heart rate, and temperature, as well as a normal electrocardiogram, which is a test that records the electrical activity of your heart.

Who cannot join the trial?

15 criteria

People with an organic condition, which means a physical disease or bodily problem, or a psychic condition, which refers to a mental health issue.
People with significant changes in their blood tests, specifically those showing damage to the liver (the organ that cleans your blood) or the kidneys (the organs that filter waste from your blood).
People who have taken any investigational drugs, which are experimental medicines being tested in other studies, within the last 3 months.
People who are unable to follow the study instructions or work together with the research team.
People who have a history of difficulty swallowing.
People with lactose intolerance, which is the inability to digest the sugar found in milk.
People who have taken prescribed medicine in the last 15 days or any type of medicine in the 48 hours before the study drug.
Women must use a reliable form of contraception, which is a method used to prevent pregnancy, for at least 4 weeks before the study and continue using it throughout.
People whose Body Mass Index (BMI), a measure of body fat based on height and weight, is lower than 18.5 or higher than 30.0.
People with a history of sensitivity, or allergic reactions, to any medication.
People who test positive for drugs such as cannabis, opiates, cocaine, or amphetamines during a drug screening.
People who are smokers.
People who drink alcohol every day or have had acute alcohol poisoning, which is sudden and severe alcohol intoxication, in the last week.
People who have donated blood within one month before the study begins.
Women who are pregnant or breastfeeding.

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Verified sites

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Verified
Hospital Universitario De La Princesa
Madrid, Spain

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Investigated drugs

Apixaban is a medication used to prevent blood clots from forming in the body.

Apixaban

What is already known about the treatment

Apixaban
This medication is taken by mouth in the form of film-coated tablets to help prevent the formation of dangerous blood clots. It is an established medicine widely used in clinical practice to treat conditions like thrombosis and to reduce the risk of stroke in certain patients. It works by blocking a specific protein in the blood called Factor Xa, which stops the chemical process that leads to clot formation. This drug belongs to a group of medicines known as direct oral anticoagulants.
Apixaban
This medication is taken by mouth in the form of hard capsules to help prevent the formation of dangerous blood clots. It is an established medicine widely used in clinical practice to treat conditions like thrombosis and to reduce the risk of stroke in certain patients. It works by blocking a specific protein in the blood called Factor Xa, which stops the chemical process that leads to clot formation. This drug belongs to a group of medicines known as direct oral anticoagulants.

Investigated diseases

Thrombosis - This condition occurs when a blood clot forms inside a blood vessel. The clot can obstruct the normal flow of blood through the circulatory system. It may develop in arteries or veins anywhere in the body. As the clot grows, it can block blood from reaching specific organs or tissues. The process can lead to localized swelling or changes in blood circulation.