Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of loperamide.

This research study is comparing two formulations (types) of a medicine called loperamide, which is often used to treat diarrhoea. We want to see if both versions are absorbed into the body and work in the same way. To do this, we're inviting healthy volunteers to take part. This is a very early stage of testing, known as a 'bioequivalence study,' which means we're checking if the new version of the medicine acts like the existing one. Your participation would help us understand how these medicines behave, ensuring that future treatments are as effective as expected. It's a key step in bringing new or updated medicines to people safely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

31 Oct 2024

Healthy volunteers

What is this study about?

This study is looking into a medicine called loperamide, which you might know as a common treatment for upset stomachs or diarrhoea. When doctors or scientists develop a new version of an existing medicine, or if different companies make the same medicine, it's really important to make sure they all work in the same way.

That's what this study is all about. We're comparing two different 'formulations' of loperamide. A formulation is simply how the medicine is made and put together, like whether it's a tablet, a capsule, or a liquid. We want to find out if both formulations release the medicine into your body at the same speed and to the same extent. This is called 'bioequivalence' – it means checking if they are effectively the same once they are inside you.

Understanding bioequivalence is crucial because it helps ensure that new versions of medicines are as safe and effective as the originals. By taking part, you would be helping us make sure that when someone takes loperamide, no matter which version, their body processes it as expected, leading to the same helpful effect.

Key takeaways

This study compares two different types of loperamide, a medicine for diarrhoea.
We need healthy adults aged 18 and over to take part.
The aim is to check if both versions of the medicine are absorbed the same way by the body.
This helps ensure medicines are safe and work as expected.
Your participation helps improve understanding of how medicines behave.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, we are looking for healthy people aged 18 years and older. There is no upper age limit, so adults of any age are welcome to consider participating.

Both men and women can join this study. The main requirement is that you are generally healthy, as the study needs to see how the medicine works in typical, healthy bodies without other health conditions getting in the way.

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 in good health?
Are you able to visit the study clinic as required?
Do you understand that you will be taking loperamide?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to visit our clinic a few times. During these visits, you will receive a dose of one of the loperamide formulations, and then, after a short break, you would receive the other formulation. Throughout your visits, we will take blood samples to measure how the medicine is absorbed and leaves your body. You will also have regular health checks to make sure you are feeling well. We will explain how many visits are needed, how long each visit will be, and the total length of your involvement in the study.

Potential risks and benefits

Taking part could offer you the benefit of contributing to medical science and helping to ensure that medicines are safe and effective for everyone. There may not be a direct health benefit to you as an individual. Potential risks are generally mild and similar to those you might experience with any medicine, such as minor side effects from loperamide itself, or discomfort from blood tests. We will explain all possible risks in detail before you decide to join. You are always free to change your mind and 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.

—
Unverified
Spain

Common questions

What is loperamide?

Loperamide is a common medicine used to help stop diarrhoea or treat upset stomachs.

What does 'bioequivalence' mean?

It means checking if two different versions of the same medicine are absorbed by the body in the same way, so they have the same effect.

Will I get the actual medicine or a dummy pill?

You will receive both formulations of loperamide at different times during the study; there are no dummy pills (placebos) in this specific type of trial.

How long will my involvement in the study last?

The total duration of your participation, including visits and follow-up, will be clearly explained to you before you agree to join.

Will I be paid for taking part?

Information about any payment or reimbursement for your time and expenses will be provided in detail by the study team.