An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Brivaracetam Tablets Ph. Eur. 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Briviact (brivaracetam) 100 mg film-coated tablets, Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium; Manufactured by UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium, in healthy adult, human subjects under fasting condition.
This is a study for healthy adults who don't have epilepsy. It's designed to compare a new version of an epilepsy medication (called Brivaracetam) made by Sun Pharma with an existing, approved version (called Briviact). The main goal is to see if the new medicine acts in the body in the same way as the approved one. This type of study, called a bioequivalence study, helps ensure that different versions of a drug are just as safe and effective. Participants will take each drug on separate occasions to allow for a direct comparison under controlled conditions, specifically while fasting. It's an early-stage study, focusing on how the body handles the drugs.
At a glance
What is this study about?
This study aims to make sure that a new version of an epilepsy medicine works exactly like an already approved one. Let's imagine you have a favourite brand of crisps, and another company starts making their own version. This study is like checking if those new crisps taste and feel the same as your favourite brand, ensuring they give you the same enjoyment.
The medicine being tested is called Brivaracetam, which is used to treat epilepsy. One version is already available and known as Briviact. A different company, Sun Pharmaceutical Industries Limited, has made its own version. For doctors to be confident prescribing this new version, they need to know it behaves identically in the body. This is crucial for medicines, as even tiny differences can affect how well they work or if they cause side effects.
So, researchers will give healthy volunteers both the new version and the approved Briviact, at different times. They will then take blood samples to measure how much of the drug gets into the body and how quickly. If the levels are very similar, it means the new version is 'bioequivalent' – which essentially means it's just as good and will work the same for patients who need it for their epilepsy.
Key takeaways
- This study compares a new epilepsy drug with an existing one.
- It aims to prove the new drug works just as well as the original.
- Only healthy adults without epilepsy can take part.
- Participants will take both drugs at different times.
- Blood tests will be used to compare how the drugs act in the body.
- Participation helps ensure new epilepsy medicines are safe and effective.
Who may be eligible?
This study is specifically looking for healthy adults. You don't need to have epilepsy to take part; in fact, people with epilepsy are not eligible for this particular study. This is because the study wants to see how the drugs behave in a body that isn't already affected by the condition or other medications.
To join, you must be 18 years old or older. There is no upper age limit mentioned, so as long as you are generally healthy, you could be considered. Both men and women are welcome to participate. Researchers will check your overall health carefully to make sure it's safe for you to take part.
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?
- Do you NOT have epilepsy?
- Are you able to follow specific fasting instructions?
- Are you available for multiple clinic visits, possibly overnight stays?
What does participation involve?
If you decide to take part, you'll be involved in what's called a 'crossover' study. This means you won't just take one drug; you'll take both the new Brivaracetam and the existing Briviact, but at different times. Before each time you take a drug, you'll need to fast (not eat) for a certain period. You'll visit the study clinic multiple times for several days, possibly including overnight stays, where blood samples will be taken regularly after you've taken each medication dose. There will be a 'washout period' between taking the two different drugs, which is a break to ensure the first drug has completely left your system before you take the second. The total duration of your participation, including all visits and the washout period, will be explained fully before you decide to join.
Potential risks and benefits
Locations (1)
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Common questions
What is 'bioequivalence'?
It means two different versions of a medicine work the same way in the body, delivering the same amount of drug at the same speed.
Do I need to have epilepsy to join this study?
No, this study is actually for healthy adults who do not have epilepsy.
Will I get paid for taking part?
The information provided doesn't mention payment, but it's a common practice in such studies. You should ask the study team directly.
What does 'fasting condition' mean?
It means you won't be allowed to eat anything for a certain number of hours before and sometimes after taking the study medicine.
What kind of medication is Brivaracetam?
It's a medicine used to help control seizures in people who have epilepsy.
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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