Bioequivalence of Eltrombopag 75 mg Film-Coated Tablets: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fed Conditions.
This study is comparing two slightly different forms of a medicine called Eltrombopag (one is called Eltrombopag and the other Eltrombopag Olamine). Eltrombopag is used to treat serious blood conditions such as aplastic anemia (where your body doesn't make enough new blood cells) and thrombocytopenia (where you have too few platelets, which help blood clot). Healthy volunteers will take one dose of each medicine at different times. Researchers will then measure how much of the medicine gets into the bloodstream and how long it stays there. The main goal is to see if these two versions of the drug behave identically in the body. They will also carefully monitor participants for any side effects.
At a glance
What is this study about?
This study is looking at a medicine called Eltrombopag. This medicine helps people who have blood conditions like aplastic anemia or thrombocytopenia. Aplastic anemia means your body doesn't produce enough new blood cells, and thrombocytopenia means you have very low levels of platelets, which are important for blood clotting.
The main aim of this study is to compare two slightly different forms of Eltrombopag. One is simply called 'Eltrombopag' and the other is 'Eltrombopag Olamine'. Sometimes, drugs can be made in slightly different ways, and it's important to make sure they work just as well and are absorbed by the body in the same way. This is a common and important part of testing medicines.
To do this, healthy volunteers will be given a single dose of each form of the medicine at different times. Researchers will take blood samples over a few days to see how quickly the medicine enters the bloodstream, how much of it gets there, and how long it takes for the body to get rid of it. This helps them understand if the two forms of the drug act in the same way. They will also keep a very close eye on the health of the volunteers to make sure the medicine is safe and check for any side effects.
Key takeaways
- This study compares two forms of Eltrombopag medication.
- It aims to see if both forms are absorbed by the body in the same way.
- Only healthy volunteers aged 18 and over can participate.
- Participation involves taking medicine and having regular blood tests.
- Your safety will be closely monitored throughout the study.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for healthy volunteers who are at least 18 years old. There's no upper age limit, meaning older adults can take part as long as they are otherwise healthy. Both men and women are welcome to participate.
It's very important that you are generally in good health to be part of this study. This means you shouldn't have any major ongoing health problems. The researchers will carry out careful checks to make sure you are suitable and that participating would be safe for you.
If you have any chronic medical conditions, or are taking regular medications, you might not be suitable for this study. Always discuss your full medical history with the study team.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you generally in good health?
- Do you have any serious ongoing medical conditions?
- Are you currently taking any prescription medications?
- Are you comfortable with regular blood tests?
What does participation involve?
If you decide to take part, you'll be asked to come to a study clinic for several visits. You'll receive a single dose of one version of the Eltrombopag medicine, and then, after a break, you'll receive a single dose of the other version. This is usually done over two separate stays or visits a few weeks apart.
During your time in the study, you'll have blood samples taken regularly to measure the medicine levels. The medical team will also closely monitor your heart (using an ECG), check your blood pressure and heart rate (vital signs), and perform various lab tests to make sure you're well. They will also ask about any side effects you might experience.
The total duration of your participation, including all visits and follow-up, will be clearly explained to you by the study team before you agree to take part.
Potential risks and benefits
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Common questions
What is Eltrombopag?
Eltrombopag is a medicine used to treat certain blood disorders where the body doesn't produce enough blood cells or platelets.
Who can take part in this study?
Healthy adult volunteers aged 18 or over, of any gender, are invited to participate.
Why are you giving this medicine to healthy people?
By testing on healthy people, researchers can clearly see how the body absorbs and processes the medicine without other health conditions complicating the results. This helps compare how two versions of a drug work.
What kind of tests will I have?
You'll have blood tests, heart checks (ECGs), and your blood pressure and heart rate will be monitored.
Will I be paid for taking part?
Often, healthy volunteer studies offer compensation for your time and inconvenience. The study team will provide full details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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