Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of linagliptin

This research is a 'bioequivalence' study, which means it compares two different versions of a medication to see if they are absorbed into the body in the same way. The medication being tested is called linagliptin, which is used to treat type 2 diabetes. This particular study is for healthy volunteers, not people with diabetes. It's a very early-stage study, often called Phase I, and it helps ensure that new versions of existing medicines work just as well as the original. By taking part, volunteers help make sure that patients will receive effective medicines in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

08 Oct 2025

Healthy volunteers

What is this study about?

This study is testing a medicine called linagliptin. This medicine is usually given to people who have type 2 diabetes. However, this particular study isn't looking at how well it treats diabetes. Instead, it's comparing two different versions of linagliptin to see if they are absorbed into your body in exactly the same way. Think of it like comparing two different brands of a common painkiller – the aim is to make sure they both deliver the same amount of medicine to your system.

This type of research is called a 'bioequivalence' study. It's a very important step whenever a new manufacturer wants to produce a medicine that is already available. Before a new version can be given to patients, scientists need to be absolutely sure that it acts just like the original medicine inside the body. This helps guarantee that patients will get the right amount of medication and the expected treatment benefits.

This study is conducted with healthy volunteers, which means people who don't have existing health conditions, especially the one the medicine usually treats. By studying healthy people, researchers can get a clear picture of how the medicine is absorbed without other health issues potentially affecting the results. Your participation helps make sure that all future patients taking linagliptin can be confident in the quality and effectiveness of their medication.

Key takeaways

Compares two versions of a diabetes medicine.
For healthy adults, aged 18 and over.
Checks how medicine is absorbed by the body.
Involves clinic visits and samples (e.g., blood).
Helps ensure new medicines are effective for patients.

Who may be eligible?

To be able to join this study, you need to be a healthy adult aged 18 or older. The study is open to both men and women.

Being 'healthy' generally means you don't have any major ongoing health problems or illnesses that could affect how your body handles the study medication. The study team will do some checks to make sure you're healthy enough to take part safely.

There usually isn't an upper age limit for healthy volunteers in this type of study, as long as you meet all the other health requirements.

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 generally consider yourself to be in good health?
Are you able to visit a clinic for study appointments?
Are you comfortable with giving blood samples?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a few visits to a clinic. During these visits, you would be given the study medication (linagliptin). The researchers would then take blood or urine samples regularly to see how your body absorbs and processes the medicine. You might also have brief health checks, like measuring your blood pressure.

This kind of study usually has different 'periods' where you receive one version of the medicine, and then a 'washout' period where you don't take any medicine, before perhaps trying the other version. The total time you'd be involved in the study, including all visits and follow-ups, would be explained to you in detail.

Potential risks and benefits

Like all medicines, linagliptin can have side effects, even in healthy people. The study team will closely monitor you and explain all known possible risks. You might also experience some discomfort from blood tests. The main benefit of participating is knowing you are helping to ensure new medicines are safe and effective for future patients. You are always free to 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 linagliptin used for normally?

Linagliptin is a medicine usually prescribed to people with type 2 diabetes to help manage their blood sugar levels.

Why are healthy people being asked to take part?

Researchers use healthy volunteers to understand exactly how the medicine is absorbed and processed by the body, without other health conditions affecting the results.

Will I get money for taking part?

Many healthy volunteer studies offer payment for your time, travel, and inconvenience. This will be clearly explained before you agree to take part.

How long will I have to stay at the clinic?

The study will involve specific visits, some of which might be longer stays, for closer monitoring. The full schedule will be detailed to you.

Are there any long-term effects from taking this medicine if I don't have diabetes?

You will be closely monitored during and after the study for any effects. Any potential long-term risks will be fully discussed with you by the research team.