An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Lacosamide tablets USP 200 mg, manufactured by Sun Laboratories Industries Limited, India with Vimpat (Lacosamide) 200 mg film-coated tablets, Marketing Authorisation Holder UCB Pharma S.A., Belgium, in healthy adult, human subjects under fasting condition.
This research study is comparing two types of a medicine called lacosamide, which is used to help people with epileptic seizures. One is a new version made by Sun Laboratories, and the other is the well-known Vimpat by UCB Pharma. We want to find out if the new version works in the body in the same way as Vimpat. This is called a 'bioequivalence' study. We are looking for healthy adult volunteers to take part. This type of study is an important early step to ensure new medicines are just as effective and safe as existing ones. Participants will take both medicines at different times.
At a glance
What is this study about?
This study is designed to compare two different versions of a medicine called lacosamide. Lacosamide is used to treat epileptic seizures, which are bursts of electrical activity in the brain that can cause a range of symptoms. One version is the established medicine, Vimpat, and the other is a new version being developed.
The main goal is to see if the new version of lacosamide works in the body in exactly the same way as Vimpat. This is important to make sure that any new version will be just as effective and safe. Think of it like comparing two brands of a common painkiller – we want to know if they both deliver the same amount of the active ingredient to your body at the same speed. This helps ensure that patients eventually get consistent treatment, no matter which version they receive.
This is a 'Phase I' study, which means it's an early-stage study often done in healthy volunteers. It focuses on how the medicine is absorbed, distributed, processed, and removed by the body. This information is crucial before the new medicine can be made widely available to people who need it for their condition.
Key takeaways
- This study compares two versions of a seizure medicine, lacosamide.
- It aims to ensure a new version works the same as the original.
- Healthy adults (18+) are needed, not people with epilepsy.
- Participants will take both medicines and have blood tests.
- Your participation helps advance medicine for patients.
Who may be eligible?
To join this study, you need to be a healthy adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part as long as they are healthy.
This study is open to both men and women. Because this is a study looking at how a medicine works in healthy people, specific medical conditions will mean you cannot take part. The research team will carefully check your health to make sure it's safe for you to participate.
It's important that you are generally well and not taking any other regular medications that might interfere with the study medicine.
- Are you 18 years old or older?
- Are you generally healthy?
- Are you able to follow study instructions, including fasting?
- Are you comfortable with having multiple blood samples taken?
- Do you understand this is for research, not for treating a condition?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you take part, you will be given both versions of the lacosamide medicine, but at different times. The study is designed so you will take one medicine, and then after a break, you will take the other. This allows researchers to compare how your body handles each one. You will be asked to fast (not eat) before taking the medicine, and blood samples will be taken many times over several hours after you take each dose. The total duration of the study, including all visits and follow-up, will be explained by the study team.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is 'lacosamide' used for?
Lacosamide is a medicine used to help control epileptic seizures.
Why are you comparing these two medicines?
We want to see if a new version of lacosamide works just as well in the body as the existing version, Vimpat.
Do I have to have epilepsy to join?
No, this study is actually for healthy adults, not people with epilepsy. It's to understand how the medicine behaves in the body.
Will I get paid to participate?
Payment for participation to cover your time and expenses is common in these types of studies, but you should ask the study team for details.
What does 'fasting condition' mean?
It means you will not be able to eat or drink anything (other than water) for a certain period before taking the medicine.
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.