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 Fasting Conditions.
This research is looking at a new tablet form of a medicine called Eltrombopag. This medicine is used for conditions where people have a very low number of platelets in their blood, like thrombocytopenia and aplastic anemia. The main goal is to see if the new 75 mg tablet is absorbed and used by the body in the same way as the current version. This is important to make sure the new tablet is just as effective and safe. Healthy volunteers will take one dose of the medicine, and scientists will take blood samples over 72 hours to measure how much of the drug is in their system. They will also keep a close eye on the participants' health and any side effects.
At a glance
What is this study about?
Imagine you have a key that opens a very important lock. This study is like making sure a newly made copy of that key works exactly the same way as the original. The medicine Eltrombopag helps people whose bodies don't make enough blood cells called platelets, which are important for stopping bleeding. Conditions like thrombocytopenia or aplastic anemia can cause these low platelet counts.
This study, called a bioequivalence study, is designed to check if a new 75 mg tablet of Eltrombopag is absorbed by the body in the same amount and at the same speed as the version currently available. This is a very common and important step in developing new medications. If the new tablet is bioequivalent, it means it should have the same medical effects and safety profile as the existing one, just in a potentially different form or dose.
To do this, healthy volunteers will take a single dose of the medicine. Over a few days, medical staff will take blood samples to measure how much of the drug is in their body at different times. They will also carefully monitor volunteers for any side effects or changes in their health. This helps ensure that any new form of medication is just as good, before it's given to patients who need it most.
Key takeaways
- This study compares a new Eltrombopag tablet to an existing one.
- It aims to ensure the new tablet works the same way in the body.
- Healthy adults (18+) are needed to participate.
- Participation involves taking single doses and frequent blood tests over 72 hours.
- It contributes to medical knowledge, but offers no direct personal health benefits.
- Your health will be closely monitored throughout.
Who may be eligible?
This study is looking for healthy adults to take part. To be eligible, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate if they are otherwise healthy.
The study is open to both men and women. The most important thing is that you are healthy, as confirmed by medical checks, because the study wants to see how the medicine acts in a typical, healthy body without other health conditions influencing the results.
Further specific health checks will be done by the study team to make sure it's safe for you to take part. This might include checking your medical history and doing some basic tests.
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 healthy?
- Are you comfortable with regular blood tests?
- Are you able to fast (not eat) before taking medication?
- Are you available for periods of observation at a clinic (likely a few days per period)?
What does participation involve?
If you decide to take part in this study, you will first have a screening visit to make sure you are suitable. If you qualify, the study involves two separate periods of treatment, with a break in between. In each period, you will receive a single dose of Eltrombopag, either the new tablet or the existing one, but you won't know which one you're getting at the time. You will not take both versions at once. Both periods will happen under 'fasting conditions', meaning you won't eat for a certain time before taking the medicine.
After you take the dose, you will stay at the clinic for a period of time, likely several days, so that blood samples can be taken frequently over 72 hours. These samples will measure how the drug is absorbed and leaves your body. Throughout the study, nurses and doctors will monitor your health by checking your vital signs (like blood pressure and heart rate), doing ECGs (heart tests), and taking routine blood and urine samples. The total duration of your involvement, including screening, both treatment periods, and follow-up, will be explained in detail.
Potential risks and benefits
Locations (1)
- —UnverifiedPortugal
Common questions
What is Eltrombopag used for?
Eltrombopag is a medicine that helps people who have a very low number of platelets in their blood, which can happen with conditions like thrombocytopenia or aplastic anemia.
What does 'bioequivalence' mean?
It means the study is checking if a new version of the medicine is absorbed into the body in the same way and at the same rate as an existing version, making sure it works just as well.
Will I get both the new and old versions of the medicine?
Yes, over two separate periods, you will receive one dose of each version – the new tablet and the existing one – but at different times.
How long will I have to stay at the clinic?
After each dose, you will need to stay at the clinic for a period, likely a few days, for blood samples to be taken over 72 hours.
Will taking part benefit my own health?
This study is for healthy volunteers and will not directly improve your health. Your participation helps develop new medicines for others.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.