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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Site Name	City	Country	Status
Hzspiohu Umlkaqmrnzcwh Du Lt Pscixkmz	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	21.08.2023

Trial locations

Investigated drugs:

Apixaban

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

Investigated diseases:

Thrombosis

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.

Trial ID:

2023-506035-15-00

Protocol code:

UECHUP-API/23-2

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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