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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 study about?

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.

1 Single dose administration in first period

During this step, a single dose of apixaban 5 mg will be administered to you in the form of a film-coated tablet.

The medication will be taken orally, which means by mouth.

The administration will occur while you are fasting, meaning you should not have eaten before taking the medication.

This is one formulation of the medication that will be tested in the study.

2 Blood sample collection after first dose

After taking the first dose, blood samples will be collected from you at specific times.

These samples are used to measure how much of the medication is present in your blood over time.

The measurements will help determine parameters such as AUC0-t, which represents the total amount of medication in your blood over a specific time period, and Cmax, which is the highest concentration of medication reached in your blood.

Additional measurements include AUC0-∞, representing the total amount of medication over an extended time, and Tmax, which is the time it takes to reach the highest concentration.

3 Washout period between doses

A washout period will occur between the two treatment periods.

This is a time interval during which no medication is administered, allowing the first dose to be completely eliminated from your body before the second dose is given.

This period ensures that the results from the second period are not affected by the first dose.

4 Single dose administration in second period

After the washout period, you will receive a single dose of the alternative formulation of apixaban 5 mg as a film-coated tablet.

The medication will again be taken orally while you are fasting.

This is the second formulation being tested, which will be compared to the first one you received.

The study uses a crossover design, meaning each participant receives both formulations at different times.

5 Blood sample collection after second dose

Following the second dose, blood samples will be collected from you at specific times, similar to the first period.

These samples will measure the same parameters as in the first period to allow comparison between the two formulations.

The collected data will be used to evaluate whether the two formulations have similar effects on your body.

6 Final assessments

After completing both treatment periods, final assessments will be conducted.

These may include physical examinations, vital signs measurements, and laboratory tests to ensure your health status.

The data collected throughout the study will be analyzed to determine if the two formulations of apixaban are bioequivalent, meaning they work in the same way in your body.

Who Can Join the Study?

    Requirements to participate in this study:

  • 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 Study?

  • 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

Where you can join this trial?

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Other Sites

Site Name City Country Status
Htksjdup Umqnloofwesiu Dx Le Piqlrmfy Madrid Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.03.2023

Trial locations

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.

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 ID:
2023-503970-19-00
Protocol code:
N-API-23-276
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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