Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Linagliptin 5 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions

This research study, called a bioequivalence study, is looking at a new version of a 5mg tablet called Linagliptin. This medicine is normally used to help people with type 2 diabetes manage their blood sugar. The main goal is to check if this new tablet is absorbed into the body in exactly the same way as the original version of the medicine. To do this, healthy adult volunteers will take the tablet on an empty stomach. Researchers will then take blood samples to measure how much of the medicine gets into their bloodstream and how quickly. This helps ensure that the new tablet will be just as safe and effective as the original, even though it might be made by a different company or in a slightly different way. This kind of study is a standard part of developing new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Tecnimede-Sociedade Tecnico-Medicinal S.A.

Enrolment target

Start

27 Sep 2024

No medical condition.

What is this study about?

Imagine you have a favourite brand of crisps, and another company starts making crisps that look and taste very similar. This study is a bit like that, but for medicine. Researchers are looking at a new version of a tablet called Linagliptin, which is a medicine used by people with type 2 diabetes to help control their blood sugar levels. They want to make sure this new version works in exactly the same way as the original, established tablet.

The main aim of this study is to see if the new tablet gets into your body and bloodstream at the same speed and in the same amounts as the original. This is called 'bioequivalence' – it just means the two versions of the medicine are equally effective. Healthy people are chosen for this type of early study because it helps researchers understand how the medicine behaves in a body that isn't already dealing with a health condition, making the results clearer.

Ensuring that different versions of a medicine are bioequivalent is really important. It means doctors can confidently prescribe any version of the tablet, knowing it will work just as well for patients. This helps ensure people have access to effective medicines, and sometimes, it can even help make medicines more affordable.

Key takeaways

This study checks if a new version of a diabetes medicine works like the original.
It's for healthy adults, aged 18 and over.
You'll take the medicine on an empty stomach at a clinic.
Blood samples will be taken to see how your body absorbs the medicine.
Your participation helps ensure new medicines are safe and effective.
You can stop taking part at any time with no questions asked.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or over. This means you shouldn't have any serious ongoing medical conditions, and you won't be taking any other regular medicines.

Because this is an early-stage study to understand how the medicine behaves, it's designed for people who are generally well. Both men and women are welcome to take part. Researchers will do checks to make sure you're healthy enough before you start.

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 in generally good health?
Do you currently not have any serious ongoing medical conditions?
Are you not taking any regular prescription medicines?
Are you comfortable having regular blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the study clinic a few times. During these visits, you'll be given the study medicine, Linagliptin, to take on an empty stomach. You'll then have blood samples taken regularly over several hours to see how your body absorbs the medicine. You might also have other checks, like your blood pressure and heart rate. You'll likely stay at the clinic for certain periods after taking the medicine so staff can monitor you. The total study duration, including all visits and follow-up, will be explained fully before you decide to join.

Potential risks and benefits

The main benefit of taking part in this study is that you'll be contributing to important medical research, helping to ensure that new versions of medicines are safe and work well. There are no direct medical benefits for you as an individual, as you are healthy and not receiving treatment for an illness. Like all medicines, Linagliptin can have side effects, and you will be closely monitored for any reactions. Possible side effects will be fully explained before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Portugal

Common questions

What is Linagliptin used for?

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

Why is this study only for healthy people?

Researchers use healthy volunteers in early studies to get a clear picture of how the medicine works in the body without other health conditions making the results harder to understand.

What does 'bioequivalence' mean?

It means the new version of the medicine works in exactly the same way as the original: it's absorbed at the same rate and in the same amount by your body.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and inconvenience. This will be openly discussed with you before you agree to participate.

Will I be given the actual diabetes medicine?

Yes, you would be given the Linagliptin 5 mg tablet. Researchers will monitor you closely to understand its effects.