Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, crossover bioequivalence clinical trial of linagliptin 5 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.

This study is looking at a medicine called linagliptin, which is used to help people with diabetes. We want to see if a new version of this medicine, in a 5mg tablet, is absorbed by the body in the same way as the original. This is important to make sure that any new version of a medication will work just as well as the one people are used to. Healthy volunteers will take a single dose of the medicine on different occasions, and doctors will check how much of the medicine gets into their bloodstream. This type of study, called a bioequivalence study, is a standard part of developing new medicines and helps ensure they are safe and effective for patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Alter S.A.

Enrolment target

Start

10 Aug 2023

diabetes

What is this study about?

This study is a type of medical research that looks into how safe and effective a new medication is before it's widely used. Specifically, it's about a medicine called linagliptin, which helps people manage diabetes. When a company makes a new version of an existing medicine, perhaps with a different coating or from a different factory, they need to prove it works exactly the same way as the original.

Think of it like this: if you have a favourite brand of crisps, and another company starts making their own version, you'd want to be sure they taste the same! In medicine, this is much more serious. We need to be sure the new tablet delivers the same amount of medicine to your body at the same speed as the original, so it has the same positive effects for your health.

This study will involve healthy volunteers taking a single dose of the linagliptin tablets. Doctors will then carefully measure how the medicine gets into and leaves their bloodstream. This helps confirm that the new tablet is just as good as the original. This is a very important step to make sure patients with diabetes will continue to receive effective treatment.

Key takeaways

Tests a new version of linagliptin, a diabetes medicine.
Aims to prove the new tablet works just like the original.
Involves healthy adult volunteers only.
Volunteers take a single dose of the medicine.
Blood samples are taken to see how the body absorbs it.
Helps ensure medicines are safe and effective for patients.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be aged 18 or older.

This study is open to both men and women. The main requirement is that you are generally healthy, which means you don't have any major ongoing medical conditions that could affect how your body handles the medicine.

The research team will carry out some checks to make sure joining the study is safe and appropriate for you.

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?
Do you not have diabetes yourself?
Are you able to follow study instructions, like fasting?
Are you comfortable with having regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given a single 5mg linagliptin tablet on different occasions. This means you won't be taking the medicine every day. Between these doses, you'll have a 'washout' period where you don't take any study medication. This lets your body completely clear the first dose before the next one.

During each visit, doctors will take blood samples at specific times to measure how much of the medicine is in your system. You might also have other routine health checks, like measuring your blood pressure. The total duration of your participation will depend on how many times you need to take the medicine and how long the washout periods are, but these types of studies usually last a few weeks in total.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical science and helping to ensure new diabetes medications are safe and effective for future patients. You might also receive compensation for your time and travel. Potential risks could include minor discomfort from blood draws, or very rarely, unexpected side effects from the medication, even though it's an approved medicine. Remember, you can ask questions at any time and you are completely free to withdraw from the study at any point without giving a reason, and it won't affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is linagliptin?

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

Why is this study needed if linagliptin is already available?

This study is to check if a new version of the linagliptin tablet works exactly the same as the original, which is a standard safety and quality step for medicines.

Will I get the actual diabetes medicine or a dummy pill?

You will receive the actual linagliptin medicine. There are no dummy pills (placebos) in this specific type of study.

Do I need to have diabetes to join this study?

No, this study is actually looking for generally healthy volunteers, not people with diabetes.

What does 'fasting conditions' mean?

It means you will be asked not to eat or drink anything (except water) for a certain period before taking the medicine, to make sure food doesn't affect how your body absorbs it.