A Study Comparing Eltrombopag Tablets in Healthy Volunteers to Test if Two Forms of the Medicine Work the Same Way in the Body After Taking with Food

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What is this study about?

This study examines Eltrombopag, a medication used to treat certain blood conditions. The conditions being studied are Aplastic anemia, which is a disorder where the body stops producing enough new blood cells, and Thrombocytopenia, which is a condition characterized by low levels of platelets in the blood. Platelets are small blood cells that help the blood to clot and stop bleeding. The study will use Eltrombopag in the form of film-coated tablets containing 75 milligrams of the active ingredient eltrombopag olamine, which works by stimulating the body to produce more platelets.

The purpose of this study is to compare two different versions of Eltrombopag tablets to see if they work in the same way in the body when taken with food. This is called a bioequivalence study, which means researchers want to confirm that both versions of the medicine are absorbed into the bloodstream at similar rates and amounts. The study will involve healthy volunteers rather than patients with the conditions mentioned, as this is a standard approach for testing whether different versions of a medication behave similarly in the body.

Participants will receive a single dose of each version of the medication on two separate occasions, with a break between doses. They will take the medication after eating a meal, as the study examines how the medicine works under fed conditions. During the study, blood samples will be collected at various times to measure the amount of medication in the bloodstream. The safety of the medication will also be monitored by checking for any unwanted effects, performing heart tracings, measuring vital signs like blood pressure and heart rate, and conducting laboratory tests on blood samples.

1 Initial screening and preparation

Your eligibility for the study will be confirmed through various assessments.

A physical examination will be performed to check your overall health status.

A 12-lead ECG (electrocardiogram, which records the electrical activity of your heart) will be conducted to ensure there are no heart-related abnormalities.

Blood and laboratory samples will be collected to verify that your clinical laboratory test results are within acceptable ranges.

Tests will be performed to confirm you do not have HIV (Human Immunodeficiency Virus), Hepatitis B, or Hepatitis C infections.

A SARS-CoV-2 test will be conducted, or you will need to provide a valid EU Digital COVID-19 Recovery Certificate.

Your body mass index (BMI, a measure of body fat based on height and weight) will be calculated and must be between 18.0 and 31.0 kg/m2.

If you are female and able to become pregnant, you must agree to use an accepted form of birth control starting at least 4 weeks before receiving the first dose of the study medication.

2 First treatment period

You will be randomly assigned to receive either the test product or the reference product of Eltrombopag 75 mg film-coated tablet.

The tablet will be taken orally (by mouth) as a single dose.

The medication will be administered under fed conditions, meaning you will take it after eating a meal.

Blood samples will be collected at specific times to measure the amount of medication in your bloodstream. These samples will be taken from before you take the dose up to 72 hours after administration.

Your safety will be monitored throughout this period through assessments of any side effects, ECG measurements, vital signs (such as blood pressure, heart rate, and temperature), and clinical laboratory tests.

3 Washout period

A period of time will pass between the first and second treatment periods to allow the medication from the first dose to be completely eliminated from your body.

During this time, no study medication will be administered.

4 Second treatment period

You will receive the other formulation of Eltrombopag 75 mg film-coated tablet that you did not receive in the first treatment period. If you received the test product first, you will now receive the reference product, or vice versa.

The tablet will be taken orally as a single dose.

The medication will again be administered under fed conditions, meaning you will take it after eating a meal.

Your safety will continue to be monitored through assessments of any side effects, ECG measurements, vital signs, and clinical laboratory tests.

5 Final safety assessment

After completing both treatment periods, a final evaluation will be conducted to assess your overall safety and well-being.

Any side effects experienced during the study will be reviewed.

Final vital signs, ECG, and clinical laboratory tests may be performed to ensure you are in good health at the conclusion of the study.

If you are female and of childbearing potential, you must continue using birth control for at least 1 week after receiving the last dose of study medication.

Who Can Join the Study?

You must provide free written informed consent, which means you agree in writing to participate in the study before any study procedures begin.
You must be willing to accept and follow all study procedures and rules.
If you are a woman, you must either be unable to have children, or if you can have children, you must agree to use an accepted birth control method starting at least 4 weeks before the first dose and continuing until at least 1 week after the last dose.
You must have a negative test result for SARS-CoV-2, which is the virus that causes COVID-19, or have a valid EU Digital COVID-19 Recovery Certificate showing you have recovered from COVID-19.
You must be between 18 and 55 years old at the time you sign the consent form.
Your body mass index, which is a measure of your weight in relation to your height, must be between 18.0 and 31.0.
You must not have any significant diseases in your medical history, which is the record of your past health conditions.
You must not have any significant abnormalities during a physical examination, which is when a doctor checks your body.
You must not have any significant abnormalities on a 12-lead ECG, which is a test that measures the electrical activity of your heart.
You must not have any significant abnormalities in clinical laboratory tests, which are blood and urine tests that check how your body is functioning.
You must test negative for HIV, which is the virus that causes AIDS, Hepatitis B, which is a liver infection, and Hepatitis C, which is another type of liver infection.
You must be a non-smoker or have stopped using tobacco or nicotine products for at least 3 months before the screening visit.

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate, as the exclusion criteria section is empty in the provided information
Generally, clinical trials have exclusion criteria to ensure patient safety, but these specific details are not available in the current study documentation
If you have aplastic anemia (a condition where your bone marrow does not make enough new blood cells) or thrombocytopenia (a condition where you have a low number of platelets, which are cells that help your blood clot), this study is related to these conditions
The study involves testing whether two products work the same way in the body when taken with food, which is called checking for bioequivalence

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bakvcgxtgvzu Ibyscizbtnmz E Dlcjnlqcwycovew El Sbuxb Luql	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	13.03.2023

Trial locations

Eltrombopag is a medication used to help the body make more platelets. Platelets are blood cells that help stop bleeding by forming clots. This medicine is often given to people who have low platelet counts due to certain medical conditions.

Investigated diseases:

Thrombocytopenia

Aplastic anemia – Aplastic anemia is a rare blood disorder in which the bone marrow fails to produce enough new blood cells. The bone marrow becomes damaged and is unable to make sufficient red blood cells, white blood cells, and platelets. This condition develops when the stem cells in the bone marrow are injured or destroyed. As the disease progresses, patients experience a decrease in all types of blood cells, a condition called pancytopenia. The reduced number of red blood cells leads to fatigue and weakness, while low white blood cell counts increase susceptibility to infections. Decreased platelet levels result in easy bruising and bleeding problems.

Thrombocytopenia – Thrombocytopenia is a condition characterized by an abnormally low number of platelets in the blood. Platelets are small blood cells that help with blood clotting and stop bleeding. This condition can develop due to decreased platelet production, increased destruction of platelets, or abnormal distribution of platelets in the body. As thrombocytopenia progresses, the reduced platelet count impairs the blood’s ability to clot properly. Patients may experience easy bruising, prolonged bleeding from cuts, and spontaneous bleeding from the gums or nose. In some cases, small red or purple spots called petechiae may appear on the skin.

Trial ID:

2022-502702-32-00

Protocol code:

BLCL-ELT-FDA-02

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A Study Comparing Eltrombopag Tablets in Healthy Volunteers to Test if Two Forms of the Medicine Work the Same Way in the Body After Taking with Food

What is this study about?

Who Can Join the Study?

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