Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of loperamide.

This study, called a bioequivalence trial, is looking at two different forms of a medicine called loperamide. Loperamide is often used to treat diarrhoea. The main goal is to check if both forms are absorbed into the body in the same amount and at the same speed. This is important to make sure they will have the same effect. We are looking for healthy adult volunteers to take part. By joining, you'll be helping medical science ensure that medicines are effective and safe for everyone. This is a very early stage of medicine testing.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

15 Oct 2025

Healthy volunteers

What is this study about?

This research study is called a 'bioequivalence' trial. In simple terms, 'bioequivalence' means checking if two different versions of the same medicine act the same way in your body. We're looking at a medicine called loperamide, which is commonly used to help stop diarrhoea. When a medicine is made by different companies, or in slightly different ways, it's really important to make sure they are all equally effective and safe.

The main aim of this study is to see if, after you take them, both versions of the loperamide medicine get into your bloodstream in the same amount and at the same speed. If they do, then we can be confident that they will have the same calming effect on your digestive system. Think of it like comparing two different brands of bottled water – they might look different, but you want to know they're both just plain water inside.

This type of study is crucial because it helps regulatory bodies, like the MHRA in the UK, make sure that all available medicines are just as good as each other. It means doctors and pharmacists can confidently prescribe or dispense different brands, knowing they will all work as expected for patients. Your participation helps us confirm that patients will receive consistent and effective treatment, no matter which version of the loperamide medicine they are given.

Key takeaways

Tests if two loperamide medicines work the same.
Needs healthy adults, aged 18 or over.
Involves taking medicine and having blood tests.
Helps ensure consistent medicine quality for everyone.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

This study is specifically for healthy volunteers. This means you should generally be in good health and not have any serious ongoing medical conditions.

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, as long as you meet the other health requirements. Both men and women are welcome to take part in this research.

More detailed health checks will be done by the study team to make sure it's safe for you to participate. These checks might include looking at your medical history, doing a physical exam, and taking some blood samples.

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 several study appointments?
Are you comfortable with having blood samples taken?
Are you willing to follow specific instructions about taking medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given both versions of the loperamide medicine at different times, usually over several study visits. You'll switch between the two medicines, often with a 'washout' period in between when you don't take any study medicine. This allows your body to clear out the first medicine before you take the second.

During your visits, which may involve stays at the research clinic or outpatient appointments, study staff will regularly take blood samples to measure how much of the loperamide medicine is in your body and how quickly it's absorbed. You might also have regular health checks, such as blood pressure and heart rate measurements. The total duration of your involvement, including all visits and follow-ups, will be clearly explained before you agree to join.

Potential risks and benefits

Participating in this study might offer a small financial payment for your time and inconvenience. While you won't directly benefit from the medicine itself as a healthy volunteer, you'll be making a valuable contribution to medical science, helping to ensure medicines are safe and effective for others. There are some potential risks, such as discomfort from blood draws, or rare side effects from the loperamide medicine, although these are generally mild. All potential risks will be fully explained before you join. Remember, you can choose 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
Spain

Common questions

What is loperamide?

Loperamide is a common medicine used to help treat diarrhoea.

Why do healthy people need to take part?

Healthy volunteers help us see how the medicine works in a typical body without other health conditions making it complicated.

Will I get paid for taking part?

It's common for volunteers in this type of study to receive some payment for their time and travel, but this needs to be confirmed with the study team.

What if I experience side effects?

The study team will monitor you closely for any side effects and will explain what to do if you feel unwell. Your safety is their top priority.

Is this a new medicine?

No, loperamide is a well-known medicine. This study is comparing two different versions of it, not inventing a new one.