Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A randomised, open-label, reference-replicated crossover trial to investigate the bioequivalence of two formulations of Silexan 80 mg in healthy volunteers

This research is a 'bioequivalence' study, which means it's comparing two different versions of a medication called Silexan. Specifically, it's looking at two kinds of 80mg Silexan capsules to see if they behave the same way in the body. This is important to make sure that a new version of a medicine works just as effectively and safely as an existing one. The study involves healthy adult volunteers and is designed to gather information on how the body absorbs and processes the medication. It's a key step in developing new medications or improving existing ones, ensuring people get consistent and reliable treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Enrolment target

Start

02 Aug 2023

Healthy volunteers

What is this study about?

Imagine you have a favourite biscuit, and then a new company makes a very similar one. This study is a bit like that, but for medicine. It's looking at two slightly different versions of an 80mg capsule containing a medicine called Silexan. Silexan is often used to help with certain health conditions.

The main goal is to see if your body uses both versions of the Silexan capsule in exactly the same way. We want to check if the new version gets into your bloodstream and is cleared from your body at the same speed and to the same extent as the original version. If they are very similar, we say they are 'bioequivalent'. This means that if you're taking one version, switching to the other would have the same effect.

Why is this important? Well, before a new version of a medicine can be used, we need to be sure it's just as good and safe as the original. This type of study helps ensure that patients eventually receive medicine that is consistent and reliable, no matter which approved version they take. It's an early but crucial step in the journey of a medicine.

Key takeaways

This study compares two Silexan 80mg capsules to see if they work the same way inside the body.
It involves healthy adult volunteers.
The aim is to ensure new versions of medicines are just as safe and effective as existing ones.
Participation includes clinic visits and blood samples to track the medicine's journey.
It's an early-stage study focusing on how the body handles the medicine.
Your contribution helps improve future medication options for patients.

Who may be eligible?

This study is looking for healthy adults. You'd need to be at least 18 years old to take part, and there's no upper age limit, as long as you're generally well.

Anyone, whether male or female, can be considered for this study. The most important thing is that you are in good health. This means you shouldn't have any significant ongoing medical conditions or be taking medications that might interfere with the study.

The research team will carry out some health checks to make sure you're suitable. They'll explain everything clearly and answer any questions you have about what 'healthy' means for this particular study.

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 with no major ongoing medical conditions?
Are you able to attend several clinic visits as required?
Are you comfortable with having blood samples taken regularly?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to visit the study clinic multiple times. During these visits, you'll be given one of the Silexan capsules. You won't know if it's the original or the new version, and the study team won't know either until the end – this helps make the results fair. You'll switch between the two capsules at different times, so we can compare them within the same person.

After taking the capsule, blood samples will be taken regularly over several hours to see how the medication is moving through your body. You might also have other checks, like blood pressure or heart rate measurements. There will be 'wash-out' periods between taking the different capsules, meaning a break where you don't take any study medication, to make sure one dose doesn't affect the next.

The total duration of your involvement, including all visits and wash-out periods, will be explained fully by the study team before you decide to take part. You'll receive clear instructions for everything you need to do.

Potential risks and benefits

Taking part in any study has potential aspects to consider. A chief benefit to you is that you'll receive careful medical supervision and health checks throughout your participation. You'll also be contributing to important medical research that helps ensure medicines are safe and effective for everyone. Potential risks might include discomfort from blood draws, temporary side effects from the study medication (though Silexan is generally well-tolerated), or interactions with other substances. The study team will explain all known potential risks in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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?

Silexan is a medication, often in capsule form, used to help with certain anxiety-related conditions. This study focuses on how different versions of it work in the body.

What does 'healthy volunteer' mean?

A healthy volunteer is someone who doesn't have any major ongoing health problems or illnesses that would affect how the study medicine works or make taking it unsafe.

Why compare two versions of the same medicine?

It's to make sure that if a new version of a medicine is introduced (perhaps made by a different manufacturer), it works exactly the same way in your body as the original, ensuring consistent and safe treatment.

Will I know which version of the capsule I'm taking?

No, this is a 'blinded' study, meaning neither you nor the study team will know which version you're receiving at any given time. This helps to keep the study fair and unbiased.

Will I get paid for taking part?

Study participants are often reimbursed for their time and travel expenses, but this will be fully explained by the study team if you express interest.