Single dose, open-label, laboratory blinded, randomised, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study of test product Perampanel 2 mg film-coated tablets versus reference product Fycompa 2 mg film-coated tablets (Eisai GmbH) in healthy adult male and female subjects under fasting conditions.
This research is a 'bioequivalence study', which means it's testing whether two versions of the same medicine work in the same way in the body. In this case, researchers are comparing a new Perampanel 2mg tablet to an existing medicine called Fycompa 2mg, which contains the same active ingredient. Healthy adult men and women, who haven't eaten recently, will take each medicine during the study. Scientists will then measure how much of the medicine gets into their bloodstream and how quickly. The main goal is to make sure the new Perampanel tablet delivers the medicine into the body in a very similar way to the original Fycompa tablet, ensuring it will be just as effective and safe for patients. This is a common step in developing new medicines.
At a glance
What is this study about?
This study is a type of research called a 'bioequivalence study'. Imagine you have a branded item, and then another company makes a very similar version. This study is like checking if both versions do exactly the same job. In this case, researchers want to see if a new tablet containing the medicine Perampanel works in the body in the same way as an already approved medicine called Fycompa, which also contains Perampanel. Both tablets contain 2 milligrams of the medicine.
To figure this out, healthy adult volunteers will take each tablet on different occasions. Before taking the medicine, they will have fasted, meaning they haven't eaten for a certain period. After taking the tablets, blood samples will be collected over time. These samples help researchers measure how much of the medicine gets into the body and how quickly it reaches its highest level.
The main reason for doing this study is to ensure that if the new Perampanel tablet is made available, it will be just as effective and safe as the existing Fycompa tablet for patients who need it. It's a key step to make sure that different versions of a medicine deliver the same amount of the active drug to do its job.
Key takeaways
- This study compares a new Perampanel tablet with an existing one to ensure they work similarly.
- It's for healthy adult volunteers, both men and women, aged 18 and over.
- Participants will take each tablet once, with blood tests afterwards.
- The main goal is to confirm the new tablet delivers medicine into the body in the same way as the original.
- No direct health benefits for participants, but you'll contribute to important medical research.
Who may be eligible?
This study is looking for healthy adult volunteers, both men and women, who are at least 18 years old. There isn't an upper age limit mentioned, but participants must be generally healthy.
Because this study aims to see how the medicine works in a healthy person, you wouldn't be able to join if you have certain health conditions that might affect how your body handles medicines. You also can't be taking certain other medicines that might interfere with the study drug.
The research team will carry out a health check to make sure it's safe for you to take part and that you meet all the necessary requirements. This ensures the results are accurate and applies to people without underlying health issues.
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, without significant medical conditions?
- Are you able to fast (not eat) for a specified time before your study visits?
- Are you comfortable with having regular blood samples taken?
What does participation involve?
If you take part in this study, you will visit the research clinic on two separate occasions. On each visit, after an overnight fast, you will be given one of the study medicines (either the new Perampanel tablet or the existing Fycompa tablet). You won't know which one you're receiving each time, and neither will the lab that tests your blood samples.
After taking the medicine, you will need to stay at the clinic for a period of time, likely a full day, while blood samples are taken regularly to measure how the medicine moves through your body. There will be a 'washout' period between these two visits, which means a break (usually a week or more) where you don't take any study medicine. This ensures that the first medicine has completely left your system before you take the second medicine. Overall, your participation, including both dosing periods and the time in between, will last for a few weeks.
Potential risks and benefits
Locations (1)
- —UnverifiedCzechia
Common questions
What is 'bioequivalence'?
It means testing if two different versions of the same medicine deliver the active drug into the body in the same way and at the same rate, making them equally effective.
Why is this study important?
It helps make sure that a new version of a medicine works just as well as the original, providing patients with other safe and effective treatment options.
Will I receive any direct health benefits from taking part?
No, this study is about comparing medicines in healthy people, so there's no direct health benefit for participants, but you contribute to medical research.
What does 'fasting conditions' mean?
It means you won't be allowed to eat food or drink certain beverages (like coffee) for a specific number of hours before taking the study medicine.
Will I know which medicine I'm taking?
No, this is a 'blinded' study, meaning you won't know if you're taking the new tablet or the existing one on any given day.
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.