Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of linagliptin

This study is called a 'bioequivalence' trial. It's designed to compare two different forms of a medicine called linagliptin. Linagliptin is used to treat type 2 diabetes. While this study uses healthy volunteers, the information gained helps doctors decide if a new version of a medicine can be used in the same way as an older, established one. In simple terms, we want to see if the body handles both versions of the drug in the same way. This is an important step before a new medicine can be made widely available. We're looking for healthy adults to take part. Your health will be carefully monitored throughout the study to make sure it's safe for you.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

13 Jun 2024

Healthy volunteers

What is this study about?

This clinical trial is designed to compare two different versions of a medicine called linagliptin. Linagliptin is a drug primarily used to help people with type 2 diabetes manage their blood sugar levels. When a pharmaceutical company creates a new version of a medicine that already exists, or makes it in a slightly different way (for example, a new pill shape or strength), they need to prove it works just as well as the original. This is where a 'bioequivalence' study comes in.

'Bioequivalence' simply means checking if the new version of the medicine gets into the bloodstream at the same rate and to the same extent as the original. If they are 'bioequivalent', it means the body processes them in a very similar way, and they should have the same effects. This is a crucial step to ensure that any new version of a medicine is safe and effective when it eventually becomes available for patients.

For this particular study, we are looking for healthy volunteers. This is because we want to see how the medicine behaves in people who don't have existing health conditions that might affect how their body handles the drug. The results from this study will help ensure that if this new version of linagliptin is approved, it can be used with the same confidence as the existing medicine. It's an important part of making sure medicines are reliable for everyone who needs them.

Key takeaways

Study compares two versions of a diabetes medicine.
Needs healthy volunteers aged 18 and over.
Aims to ensure new medicine acts like the old one.
Involves taking medication and blood tests.
Participation helps future medicine development.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you need to be at least 18 years old.

We welcome both men and women to participate in this research. The most important thing is that you are in good general health, as this helps us understand how the medicine works in typical, healthy individuals.

Before you can join, a medical team will do a health check to make sure the study is suitable and safe for you. This will involve looking at your medical history and doing some basic tests. They will explain everything clearly, and you'll have the chance to ask any questions you have about whether you qualify.

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 in good health?
Are you available for multiple clinic visits?
Are you comfortable with blood tests?
Do you understand this is not a treatment study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to visit the study clinic for a number of appointments. During these visits, you would receive doses of the study medication (linagliptin) and have blood samples taken at various times to see how the medicine is absorbed and cleared by your body. You will be closely monitored by medical staff throughout these periods.

You would also have health checks, such as physical examinations and possibly ECGs (heart tracings), to ensure your well-being. The total duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to participate.

Potential risks and benefits

Participating in this study might not offer direct health benefits to you, as it is designed to understand the medicine, not to treat an illness. However, your involvement is crucial for helping to develop and improve medicines for wider use. As with any medication, there's a possibility of side effects, which will be fully explained to you. You will be carefully monitored by medical professionals, and your safety is the top priority. Remember, you can choose 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?

Linagliptin is a medicine used to help people with type 2 diabetes manage their blood sugar levels. This study is testing different versions of it.

Why do you need healthy volunteers?

We need healthy volunteers to see how the medicine works in people who don't have other health conditions that might change how their body reacts to the drug.

Will I get paid for taking part?

Information about payment or reimbursement for your time and travel will be discussed in detail by the study team, should you be interested in participating.

What is a 'bioequivalence' study?

It's a type of study that checks if two different versions of the same medicine work in the same way in the body. It helps make sure new medicines are just as good as existing ones.

Will I have to stay overnight?

The study team will explain the exact schedule, including how many visits you'll need and if any overnight stays are required, before you agree to participate.