Hospital Universitario De La Princesa
Madrid, Spain
Not recruiting
A Study Comparing Two Formulations of Apixaban in Healthy Volunteers to Test if They Work the Same Way in the Body
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study involves healthy volunteers and examines apixaban, a medication that helps prevent blood clots. The study will compare two different formulations of apixaban tablets, both containing 5 mg of the active ingredient. One formulation is called Eliquis, which is already available on the market, and the other is Apixabán Normon, which is a test formulation. The purpose of the study is to compare how the body absorbs and processes these two formulations and to show that they work in the same way.
The study follows a crossover design, which means that each participant will receive both formulations at different times. Participants will take a single dose of one formulation and then, after a period of time, they will take a single dose of the other formulation. The medication will be taken by mouth without food. During the study, blood samples will be collected to measure the amount of medication in the body over time. This information will help determine if the two formulations are equivalent in how they are absorbed and used by the body.
Participants in this study will be healthy volunteers between 18 and 55 years of age who do not have any significant medical conditions. They will undergo medical examinations and laboratory tests to ensure they are suitable for the study. The study is designed to evaluate whether the test formulation works in the same way as the reference formulation that is already approved for use.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- You must be able to understand information about the study design, objectives, and possible risks, and you must be willing to provide written consent, which means signing a document agreeing to take part in the study
- You must be between 18 and 55 years old
- 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 issues, and your physical examination, which is a check-up by a doctor, must show no significant abnormalities
- Your blood tests must show no significant abnormalities, including tests for haematology (blood cell counts), coagulation (how well your blood clots), biochemistry (chemical substances in your blood), 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, and your electrocardiogram, which is a test that records the electrical activity of your heart, must show no significant abnormalities
- Both men and women can participate in this study
Who cannot join the trial?
3 criteria
- The study does not provide specific exclusion criteria in the available information
- This is a study with healthy volunteers, which means people who do not have the medical condition being studied
- Generally, for studies testing medication formulations, people who cannot participate may include those with certain health conditions, but specific details are not listed in the provided information
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Investigated drugs
Apixaban is a blood thinner medication that helps prevent blood clots from forming in the body. It works by blocking certain clotting proteins in your blood. In this trial, volunteers will take this medication to compare how the body absorbs different tablet versions of the same medicine.
What is already known about the treatment
Apixaban – Apixaban is an oral anticoagulant medication that comes in the form of film-coated tablets taken by mouth, typically used to prevent blood clots in various medical conditions. This medication works by blocking a specific protein in the blood called Factor Xa, which plays a key role in the blood clotting process, thereby reducing the risk of dangerous clot formation. It belongs to a class of drugs known as direct oral anticoagulants and is commonly prescribed to prevent stroke in patients with irregular heart rhythms, treat deep vein thrombosis and pulmonary embolism, and reduce clotting risks after hip or knee replacement surgery. Apixaban is an established medication that is widely recognized in medical practice and has been extensively studied in clinical research.
Investigated diseases
Healthy volunteers – This term refers to individuals who participate in clinical research studies but do not have the disease or condition being investigated. These volunteers have no significant medical conditions that would affect the study results. They help researchers understand how medications or treatments work in people with normal health status. Healthy volunteers provide baseline data that can be compared to patients with specific diseases. Their participation is essential for testing the safety and basic effects of new drugs. These studies often focus on how the body processes medications rather than treating any illness.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503970-19-00Protocol codeN-API-23-276Estimated enrolment24 patientsSponsorLaboratorios Normon S.A.
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