Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Evaluation of the bioequivalence of two products containing esomeprazole under fed conditions: Esomeprazole-Syrup 40 mg dose (Test) vs. Nexium 40 mg (Comparator). An open, randomized, single dose, four-period, replicate, crossover trial in healthy volunteers

This research study is looking at a new liquid form of esomeprazole, a common medicine used to reduce stomach acid, often sold as Nexium. We want to see if this new liquid version works in the same way as the established pill by checking how much of the medicine gets into the body. To do this, healthy adult volunteers will take both the new liquid medicine and the existing pill at different times. The study is designed to be very careful and organised, making sure we get accurate results. It's an important step to ensure that any new medicine is just as effective and safe as the original. This particular study doesn't aim to treat any illness, but rather to understand how the medicine behaves in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, BePharBel Manufacturing

Enrolment target

Start

10 Mar 2025

No therapeutic indication in the current trial with healthy volunteers.

What is this study about?

Imagine you have a headache and take a painkiller. You want to be sure that the tablet you take delivers the right amount of medicine to your body to make you feel better. This study is doing something similar, but with a medicine called esomeprazole, which is used to reduce stomach acid. It comes in different forms, like pills and sometimes liquids.

Researchers have developed a new liquid version of esomeprazole. Before it can be widely used, they need to check that it works just as well as the existing pill version. This is like comparing two different cars to see if they both go the same speed and use the same amount of fuel, even if one is a new model.

Specifically, this study will compare the new liquid esomeprazole with the well-known pill form (called Nexium). They want to see if, after someone has eaten a meal, both forms deliver the same amount of the active medicine into the bloodstream. This is a very important step to make sure that the new liquid medicine will be effective and safe if it's eventually approved for patients.

Key takeaways

This study compares a new liquid esomeprazole with the existing pill.
It aims to ensure both medicines are absorbed by the body in the same way.
Only healthy adults aged 18 and over can participate.
The study involves taking both medicines after food and giving blood samples.
Your participation helps ensure new medicines are safe and effective.

Who may be eligible?

This study is looking for healthy adults who are 18 years old or older. You can be any gender to take part.

Because this study is about how the medicine behaves in healthy bodies, rather than treating an illness, you wouldn't be allowed to join if you have certain health conditions or are taking medications that might affect the results. They'll also check if you have any allergies to the study medicine or similar drugs.

The research team will carry out several checks and ask detailed questions about your health and medical history to make sure that it's safe for you to participate and that you meet all the necessary requirements for the 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 comfortable with giving regular blood samples?
Are you not currently taking medications that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll visit the clinic regularly over several weeks. On some visits, you'll receive either the new liquid esomeprazole or the standard esomeprazole pill after eating a meal. You will be asked to switch between these two medicines during the study. Blood samples will be taken at various times after you take the medicine to measure how much of it is in your body. This will happen over four separate periods, with a break in between each to allow the medicine to leave your system.

You'll be carefully monitored by the study team, and they'll check your general health throughout. The total duration of your participation, including all visits and follow-up, will be explained in detail before you agree to take part.

Potential risks and benefits

Taking part in any study has potential aspects to consider. A potential benefit is that you'll receive careful medical supervision and free health checks throughout the study. You'll also be contributing to important medical research that helps ensure new medicines are safe and effective for future patients. Potential risks might include discomfort from blood draws, or experiencing mild side effects from the study medicine, such as headache or stomach upset, which are typically temporary. 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
Bulgaria

Common questions

What is esomeprazole?

Esomeprazole is a medicine commonly used to reduce the amount of acid in the stomach, often prescribed for heartburn, indigestion, and acid reflux.

Why is this study using healthy volunteers?

This type of study often uses healthy volunteers to understand how the medicine behaves in the body without other health conditions or medications complicating the results.

Will I be given a new medicine for an illness?

No, this study is not designed to treat any illness. It's purely to compare how two different forms of a medicine are absorbed by the body.

What does 'bioequivalence' mean?

Bioequivalence means that two medicines deliver the same amount of the active drug to the body at the same speed, meaning they should work in the same way.

Will I know which medicine I'm taking?

The study is 'open-label,' meaning both you and the study team will know whether you are receiving the liquid esomeprazole or the pill from Nexium at any given time.