Bioequivalence of Eltrombopag 25 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions.
This research is looking at a new version of a medication called Eltrombopag, specifically a 25mg tablet. The main goal is to find out if this new tablet acts in the same way as an older, already approved version of the drug. This type of study, called a bioequivalence study, helps ensure that new versions of medicines are just as effective and safe as the originals. Healthy adult volunteers will take the new Eltrombopag tablet on an empty stomach. Researchers will then check how the medication is absorbed into their bloodstream over time. This helps the medical authorities decide if the new tablet can be used in place of the existing one.
At a glance
What is this study about?
This study is a type of medical research that looks into how different versions of the same medicine work in the body. It focuses on a drug called Eltrombopag, which is used to treat certain blood conditions, though this particular study is not treating any illness. Researchers want to see if a newly made 25mg tablet of Eltrombopag is absorbed and used by the body in exactly the same way as another already approved version of this medicine. Think of it like comparing two different brands of a common painkiller – the active ingredient is the same, but they want to confirm that both get into your system at the same speed and in the same amounts.
This kind of research is very important because it helps ensure that when a new, often more affordable, version of a medicine comes out, it works just as well and is just as safe as the original. It's about making sure that patients who need Eltrombopag can get reliable medication, regardless of which manufacturer makes it. These studies are called 'bioequivalence' studies, and they are a standard step before a new medicine version can be widely used.
The study is designed for healthy volunteers. This means people participating don't have any illness they're trying to treat with Eltrombopag. Their bodies are checked before the study to make sure they are generally healthy. They will take a single dose of the tablet on an empty stomach, and then medical staff will take blood samples over several hours to measure how much of the drug gets into their bloodstream and how quickly. This gives a clear picture of how the body handles the medicine.
Key takeaways
- This study compares a new Eltrombopag 25mg tablet with an existing one.
- It's for healthy adults to ensure the new tablet works the same way.
- Participation involves taking a single tablet and having blood samples taken.
- The study helps ensure future patients get reliable medicine.
- You'll be fully informed of any risks and have the right to leave at any time.
Who may be eligible?
To join this study, you need to be a healthy adult. This means you generally feel well and don't have any major ongoing health problems. The study is open to both men and women.
You must be at least 18 years old to take part. There isn't an upper age limit mentioned, but you'll need to pass health checks to make sure you're suitable.
Since this study is about how the medicine gets into your system, you would need to be able to take the tablet on an empty stomach, and you would need to be comfortable with having blood samples taken regularly.
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 and don't have any major ongoing medical conditions?
- Are you comfortable with taking medication on an empty stomach?
- Are you comfortable with having several blood samples taken?
- Can you commit to attending clinic visits for the study?
What does participation involve?
If you decide to take part in this study, you will be asked to visit a clinic. During your visit, you will receive a single dose of the Eltrombopag 25mg tablet. This will happen after you've fasted, meaning you won't have eaten anything for a certain number of hours before taking the medicine.
After taking the tablet, healthcare professionals will regularly take small blood samples from you over a period of time. These samples help them measure how the drug is absorbed and processed by your body. You will be monitored closely during this time.
There might be additional checks, such as measuring your vital signs (like blood pressure and heart rate) before and after you take the tablet. The total duration for your active participation, including the fasting and blood sampling, will likely be for one full day, or potentially two separate visits. You won't be taking this medicine long-term as part of this study.
Potential risks and benefits
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Common questions
What is Eltrombopag used for normally?
Eltrombopag is a medicine usually prescribed to treat conditions where the body doesn't produce enough platelets, which are important for blood clotting.
Why is this study for healthy people, not those with the condition?
Measuring how the drug is absorbed is easier and clearer in healthy people, as their existing health issues or other medications wouldn't affect the results.
Will I get paid for taking part?
It's common for healthy volunteer studies to offer payment or compensation for your time and travel, but you should always confirm this with the study team.
How long will I need to be at the clinic?
You would likely need to be at the clinic for one full day, or possibly two separate days. The exact schedule will be explained by the study team.
What does a 'fasting condition' mean?
Fasting means you can't eat anything for a specific number of hours (usually 8-10 or more) before you take the medicine, and sometimes for a period afterwards. You can usually drink water.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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