Single dose, open-label, laboratory blinded, randomised, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study of test product Perampanel 12 mg film-coated tablets versus reference product Fycompa 12 mg film-coated tablets (Eisai GmbH) in healthy adult male and female subjects under fasting conditions.
This research is looking at how two different versions of a medicine called Perampanel are absorbed by the body. One is the original medicine (Fycompa), and the other is a new version being tested. Volunteers will take each medicine at different times, and doctors will check blood levels to see how quickly and how much of the medicine gets into their system. This is done to make sure the new version works just as well and safely as the original, which is important for future patients. This type of study helps ensure that new, often more affordable, medicines are just as effective as the original ones.
At a glance
What is this study about?
Imagine you have a headache and take a paracetamol tablet. You expect it to work in a certain way – to relieve your pain. This study is similar, but it's for a medicine called Perampanel, which is used for particular health conditions. Researchers want to make sure that a new version of Perampanel works exactly like the original branded version, called Fycompa.
To do this, healthy adult volunteers will take both medicines at different times. The doctors will then take blood samples over a few days to measure how much of the medicine gets into the body and how quickly. They are specifically looking at two main things: how fast the medicine reaches its highest level in the blood (called Cmax) and the total amount of medicine that enters the bloodstream over a certain period (called AUC).
The goal is to show that the new version of Perampanel is 'bioequivalent' to the original. This means it behaves in the same way in the body, providing the same benefits and having a similar safety profile. This kind of research is really important because it allows new, often more affordable, versions of medicines to become available, so more people can access the treatment they need, knowing it will be just as effective.
Key takeaways
- Compares two Perampanel medicines to ensure they work the same.
- Involves healthy adult volunteers, both men and women.
- Tests how medicine gets into the bloodstream after a single dose.
- Helps make sure new medicines are just as effective and safe.
- Requires fasting and regular blood tests over a few days.
- Participation helps advance medical options for patients.
Who may be eligible?
This study is looking for healthy adults to take part. This means people who don't have any major health conditions that could affect how their body handles the medicine.
Both men and women are welcome to participate, as long as they are 18 years old or older. There is no upper age limit, but generally, participants need to be in good overall health.
Even if you think you fit these general criteria, there will be more detailed checks by the study team to make sure it's safe and appropriate for you to join.
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?
- Do you consider yourself generally healthy?
- Are you able to attend several clinic visits, including overnight stays for some (if needed)?
- Are you comfortable with regular blood tests?
- Are you able to follow specific instructions, like fasting before medication?
What does participation involve?
If you decide to take part, you would visit the study clinic multiple times. You'll be asked to fast (not eat or drink anything except water) before taking the medicine. On separate occasions, you will take either the test medicine (Perampanel 12 mg tablets) or the reference medicine (Fycompa 12 mg tablets).
After taking each medicine, you'll have blood samples taken regularly over a period of 72 hours (about three days). This allows the researchers to track how the medicine moves through your body. You'll be carefully monitored by the study team throughout your visits. The total duration of your involvement, including all visits and follow-up, will be explained in detail before you agree to participate.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means two medicines act the same way in the body – they get absorbed and work with similar speed and amount.
Why is this study only for healthy people?
Using healthy volunteers helps researchers understand how the medicine works without other health problems affecting the results.
Will I receive any of my usual medication?
No, this study is comparing two versions of Perampanel. If you are on other medication, you might not be suitable for this study.
What does 'fasting conditions' mean?
It means you won't be able to eat or drink anything (except water) for a certain period before taking the medicine.
Will I be paid for taking part?
Many studies offer payment or reimbursement for your time and travel, but this would be confirmed during the consent process.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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