Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of loperamide.

This study is a bioequivalence trial, which means we're comparing two versions of a medicine called loperamide. Loperamide is often used to help with diarrhoea. We want to find out if both versions deliver the same amount of medicine into your bloodstream over the same amount of time. This is important to make sure that a new or generic version of a medicine will work just as well and be just as safe as the original. We're looking for healthy adult volunteers to take part, and your participation would help ensure that medicines available to the public are always reliable and effective.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

23 Jun 2025

Healthy volunteers

What is this study about?

Imagine you have a headache and you take a painkiller. You trust that painkiller will work because it's been tested. Well, sometimes, different companies make the same medicine. When this happens, we need to check that the new version works just as well as the original one.

This study is doing just that for a medicine called loperamide. Loperamide is a common medicine used to treat diarrhoea. We're not testing a brand new medicine that's never been used before. Instead, we're comparing two different versions of loperamide that either already exist or are being developed. The main goal is to see if your body absorbs both versions in the same way and at the same speed.

This type of study, called a bioequivalence study, is really important. It helps doctors and pharmacists know that when they prescribe or dispense a medicine, different brands will have the same effect. By taking part, you'd be helping to make sure that people in the UK can always get medicines that are safe and work effectively, no matter who makes them.

Key takeaways

This study compares two loperamide medicines.
It needs healthy adults aged 18 and over.
The goal is to ensure medicines work the same.
Participation involves taking medicine and blood tests.
Helps make medicines safer and more effective for all.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers who are generally healthy. You need to be at least 18 years old, and there's no upper age limit, meaning older adults can also take part.

Because this study focuses on how medicine is absorbed in healthy individuals, you should not have any serious ongoing health problems that could affect how your body handles medicines. We'll ask you some questions about your health and might do a basic check-up to make sure it's safe for you to participate.

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?
Are you able to attend clinic appointments as required?
Are you comfortable with having blood samples taken?
Do you understand what taking loperamide involves?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive doses of two different loperamide formulations, probably on different days. This usually involves visiting a clinic, taking the medicine, and then having several small blood samples taken over a few hours to see how the medicine moves through your body. You might also be asked to provide other samples or have simple checks like blood pressure measurements. The total duration of your involvement, including all visits and follow-up, would be fully explained before you agree to anything.

Potential risks and benefits

Taking part in this study won't directly benefit your health immediately, as it's about checking existing medicines. However, your involvement helps to improve the quality and safety of medicines for everyone. Potential risks are generally low, similar to those you might experience from taking loperamide normally (like mild constipation or feeling sick) or from having blood tests (like slight bruising or discomfort). You are always free to change your mind and leave 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
Spain

Common questions

What is loperamide?

Loperamide is a common medicine that helps slow down your gut to treat diarrhoea symptoms.

Why do you need healthy volunteers?

We use healthy volunteers to see how the medicine works in a typical body, without other illnesses complicating the results.

Will I be given a real drug or a dummy pill?

In this study, you would receive active loperamide medicine, as we are comparing two active versions, not comparing to a dummy pill.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and inconvenience. This would be clearly explained to you before you agree to take part.

How long will the study appointments take?

Study appointments can vary. Some might be a few hours for blood tests after taking the medicine, while others might be shorter. All details will be provided upfront.