AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A randomized, open-label, two-period, two-sequence crossover trial to investigate the effect of food on the pharmacokinetics of Silexan 80 mg in healthy participants

This research study is designed to understand how eating food affects a specific medicine, Silexan 80mg. We want to see if the body absorbs and uses the medicine differently when it's taken with a meal versus on an empty stomach. Healthy adult volunteers will participate, taking the medicine at different times with and without food, to help scientists gather important information. This type of study, often called a 'Phase I' trial, is a crucial early step in drug development to ensure medicines can be used effectively and safely by patients.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Enrolment target

Start

09 Dec 2024

Healthy volunteers

What is this study about?

Imagine you're taking a medicine, and you wonder if it works better if you eat something first, or if it doesn't matter. This study, called a 'crossover trial', aims to answer that kind of question for a specific medicine called Silexan 80mg.

Researchers want to see if the timing of your meal makes a difference to how your body takes in and processes this medicine. We call this 'pharmacokinetics' – it's like tracking the journey of the medicine through your body. By understanding this, doctors and pharmacists can give clearer instructions on how best to take Silexan 80mg, making sure you get the most benefit from it.

Healthy volunteers are really important for this type of research. Because they are generally well, any changes we see in how the medicine behaves in their bodies are more likely due to the food, rather than other health conditions. This helps us ensure the medicine works as expected for future patients.

Key takeaways

This study explores how food affects a medicine called Silexan 80mg.
Healthy adult volunteers are needed to take part.
The research helps understand how the body absorbs and uses the medicine.
It will involve taking the medicine at different times with and without food.
Your participation helps improve how medicines are used for everyone.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 years or older. This means you generally don't have any major health problems that could affect how the medicine works in your body or make it unsafe for you to take part.

Both men and women can participate. The main goal is to study the medicine itself, not how it affects specific health conditions, which is why healthy volunteers are needed.

When you express interest, the study team will carefully check your health and medical history to make sure taking part is safe and appropriate for you.

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 with no major ongoing medical conditions?
Are you able to attend clinic visits as needed?
Are you willing to take the study medicine as instructed?
Are you comfortable with having blood samples taken occasionally?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the Silexan 80mg medicine on two separate occasions, once with food and once without, but not on the same day. There will be a 'washout' period in between to make sure all of the first dose has left your body.

You'll make several visits to the study clinic where blood samples will be taken at specific times after you've taken the medicine. These samples help researchers measure how much of the medicine is in your body and how it changes over time. You might also have other health checks, like blood pressure or heart rate monitoring, during these visits.

The total duration of your involvement, including all visits and the time between taking the medicine, will be explained fully by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to important medical knowledge that helps everyone understand how Silexan 80mg works best, which could lead to better use of the medicine for future patients. Potential risks might include mild side effects from the medicine, discomfort from blood draws, or the time commitment involved. You will be closely monitored by medical staff. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Silexan 80mg?

Silexan is a medicine. This study aims to understand how it behaves in your body.

Why is it important to know how food affects medicine?

Knowing this helps doctors and pharmacists give the best advice on how and when to take a medicine for it to work effectively and safely.

Will this study help me personally?

While this study focuses on general knowledge, your participation directly helps advance medical science for everyone.

What are 'healthy volunteers'?

These are people who are generally well and don't have major health conditions, allowing researchers to study the medicine's basic effects without other health issues complicating things.

Do I have to do exactly what the study asks?

Yes, to get accurate information, you'll need to follow the study instructions carefully, especially around timing of medicine and food.