Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of loperamide.

This important study is designed to compare two different types of a medicine called loperamide, which is commonly used to treat diarrhoea. We want to see how each version is absorbed into your body and if they work in the same way. This is known as a 'bioequivalence' study. By taking part, you'll be helping doctors understand if a new version of loperamide is just as good as one that's already available. You'll be asked to take one of the medicines, and then samples will be taken to see how it moves through your system. This research helps make sure that medicines are reliable and effective for everyone.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

29 Apr 2026

Healthy volunteers

What is this study about?

This study is all about a medicine called loperamide. You might know it as a common treatment for diarrhoea or an upset tummy. When a company makes a new version of an existing medicine, or if they change how it's made, doctors need to be sure it works just as well as the original.

That's where this study comes in. We call it a 'bioequivalence' study. This simply means we're comparing two versions of loperamide to see if your body absorbs them in the same way and at the same speed. If they are 'bioequivalent,' it means they're expected to have the same helpful effects and safety.

By taking part, you'll be helping us confirm that new or altered medicines are reliable and effective. This is a crucial step in making sure people get the best possible care when they need medication.

Key takeaways

This study compares two loperamide medicines.
It aims to see if they work the same way in the body.
Healthy adults (18+) are needed.
Participation involves taking medicine and giving blood samples.
Helps ensure medicines are effective for everyone.
You can leave the study at any time.

Who may be eligible?

This study is looking for healthy volunteers. This means people who don't have any serious ongoing health problems and are generally well.

To join, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can take part as long as they are healthy. Both men and women are welcome to participate in this 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?
Are you generally healthy?
Are you able to visit a clinic for study appointments?
Are you willing to take loperamide medication?
Are you comfortable with having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit a clinic a few times. During these visits, you'll be given one of the loperamide medicines. We'll then take small blood samples over several hours to see how the medicine is absorbed and leaves your body. You might also have some general health checks, like measuring your blood pressure.

There will be breaks between receiving the different medicines so your body can clear the first one before you try the next. The total duration of your participation, including all visits and follow-up checks, will be explained in full detail before you agree to join.

Potential risks and benefits

Taking part in a study like this doesn't directly benefit your health immediately, but it helps improve medicines for everyone in the future. The risks involved are generally low, as loperamide is a well-known medicine. You might experience some mild side effects associated with loperamide, such as constipation or feeling a bit sick, or discomfort from blood draws. You are free 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
Spain

Common questions

What is loperamide?

Loperamide is a common medicine used to help stop diarrhoea or an upset tummy.

What does 'bioequivalence' mean?

It means we're checking if two different versions of the same medicine work in the same way in your body.

Do I have to be sick to join?

No, this study is looking for healthy volunteers, meaning people who are generally well.

Will I know which medicine I'm getting?

The study team will explain how the medicines are given. Sometimes, participants don't know which version they receive (this is called 'blinding') to ensure fair results.

Will I get paid for taking part?

Compensation for your time and travel expenses is often provided in studies like this. The exact details will be explained by the study team.