Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study to compare drug availability in bloodstream of two oral formulations of mesalazine in healthy volunteers under fed conditions.

This research study is comparing two slightly different versions of a medicine called mesalazine. Mesalazine is used to treat conditions like inflammatory bowel disease (IBD). This particular study is in healthy adult volunteers and aims to see how much of the medicine gets into the bloodstream from each version when taken with food. By understanding how the body absorbs these medicines, doctors can ensure patients get the most effective treatment. It's a phase 1 study, which means it's an early look at how a medicine works in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Faes Farma S.A.

Enrolment target

Start

11 Nov 2024

Chronic idiopathic inflammatory bowel disease

What is this study about?

This study is designed to compare two different ways of taking the same medicine, mesalazine. Think of it like trying two different brands of the same vitamin – they both do the same job, but this study wants to see if one is absorbed into your body a bit better or faster than the other. Mesalazine is an important medicine for people who have long-term gut problems like inflammatory bowel disease (IBD).

The main aim here is to understand how much of the medicine gets into the bloodstream from each of these two versions after someone has eaten. This is important because the amount of medicine in your blood can affect how well it works and whether you get the right dose. By studying this in healthy people, researchers can get a clear picture without other health conditions making it complicated.

This kind of study is a very early step in developing medicines, often called a 'Phase 1' study. It helps scientists make sure that new forms of existing medicines are working as expected before they are given to patients who need them for their long-term conditions. It's all about making sure medicines are as effective and safe as possible.

Key takeaways

This study compares two versions of a medicine called mesalazine.
It aims to see how well each version is absorbed into the blood when taken with food.
Healthy adults (18 years and older, male or female) are needed as volunteers.
Participation involves taking the medicine and giving blood samples.
It's an early-stage study to improve our understanding of medicines.

Who may be eligible?

To join this study, volunteers need to be healthy adults. This means you should not have any ongoing serious health conditions that might affect how your body handles the medicine.

Specifically, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older adults could also take part if they are in good general health.

This study welcomes both men and women to participate, as gender can sometimes affect how medicines work in the body, and researchers want to understand this fully.

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 and don't have any major ongoing medical conditions?
Are you comfortable with giving blood samples?
Are you able to follow specific instructions about taking medicine and food?
Are you able to commit to several clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a few visits to a clinic. During these visits, you would be given the mesalazine medicine with a meal.

After taking the medicine, doctors or nurses would take small blood samples from you at different times. This helps them measure how much of the medicine is in your bloodstream and how long it stays there. You might also have some general health checks like having your blood pressure taken.

The total amount of time you would be involved in the study, including all visits and follow-up, would be explained to you in detail before you agree to take part.

Potential risks and benefits

The main benefit of taking part in this type of study is helping advance medical knowledge, which can eventually lead to better treatments for people with conditions like IBD. You might also receive some health checks. Potential risks could include minor discomfort from blood draws, or possible side effects from the mesalazine medicine, though these are usually mild in healthy individuals. You will be closely monitored, and you are free to withdraw from the study at any time without giving a reason, and this will not affect 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 mesalazine used for?

Mesalazine is a medicine often used to treat long-term gut conditions like inflammatory bowel disease (IBD).

Why are healthy people needed for this study?

Using healthy volunteers helps researchers understand how the medicine works in the body without other health problems complicating the results.

Will I get paid for taking part?

Some studies offer payment for your time and travel, but this would be discussed with you before you agree to participate.

What does a 'Phase 1' study mean?

Phase 1 studies are early stages of research, usually checking how safe a medicine is and how the body handles it in a small group of people.

Do I have to take the medicine with food?

Yes, this study specifically looks at how the medicine is absorbed when taken with a meal, so you would need to eat as instructed.