Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Drug-Drug Interaction between Alogliptin 25 mg Film-Coated Tablets and Empagliflozin 25 mg Film-Coated Tablets in Healthy Participants Under Fasting

This research is a small, early-stage study (called Phase I) designed to understand how two existing diabetes medicines, Alogliptin and Empagliflozin, behave in the body when taken together. Participants will be healthy volunteers, meaning they don't have any medical conditions. The main goal is to see if one drug affects how the other works or how the body processes it, especially when taken without food. This kind of research is important because it helps doctors and pharmacists understand how to best use these medications safely if they are prescribed together for people with diabetes in the future. It's about ensuring that combining these treatments is safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Tecnimede-Sociedade Tecnico-Medicinal S.A.

Enrolment target

Start

17 Feb 2025

No medical condition.

What is this study about?

Imagine you take two different medicines for different reasons. This study is like checking if those two medicines play nicely together inside your body. Researchers want to see what happens when healthy people take two diabetes medications, Alogliptin and Empagliflozin, at the same time. This isn't a study to treat diabetes; instead, it's about understanding how the drugs interact.

Think of it as a test run. The main goal is to see if one drug changes how your body uses or breaks down the other. For example, does taking one drug make the other stay in your system longer, or get rid of it faster? This information is really important for doctors. If someone with diabetes needs to take both of these medications, understanding their interaction helps doctors know if they need to adjust the doses or watch out for any special side effects.

This type of study is called a 'Human Pharmacology' study, or sometimes a 'Phase I' study. These are usually the first studies done in people, often in healthy volunteers, to gather basic information about how new treatments, or new combinations of existing treatments, work in the body. It helps build a foundation of knowledge for safer and more effective treatment options in the future.

Key takeaways

This study looks at how two common diabetes medications interact.
It involves healthy volunteers, not people with diabetes.
The goal is to understand how the body handles these drugs when taken together.
Participation helps future patients if both drugs are prescribed.
It's an early-stage study to gather basic information on drug interactions.

Who may be eligible?

To join this study, you need to be a healthy participant. This means you generally don't have any ongoing medical conditions that require treatment. The researchers are specifically looking for people who are in good health, as the study aims to understand how the medications interact without other health issues complicating the results.

You must be at least 18 years old to take part. There isn't an upper age limit mentioned, so adults of various ages could be eligible if they meet the other health criteria. Both men and women are welcome to participate in this research.

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 with no ongoing medical conditions?
Are you able to follow specific study instructions, like fasting?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive specific doses of the two medications, Alogliptin and Empagliflozin, sometimes together and sometimes separately, to see how they interact. This would likely involve staying at a clinic for a short period and having regular blood or urine samples taken to measure how the drugs are processed by your body. You would need to follow specific instructions, such as fasting (not eating) before taking the medication, as this study focuses on interactions under fasting conditions. The total duration of your involvement, including all visits and follow-ups, would be explained in detail by the study team.

Potential risks and benefits

The main benefit of participating is contributing to medical knowledge that could help people with diabetes in the future. You wouldn't directly benefit from treatment for a condition, as this study is for healthy volunteers. Potential risks include side effects from the medications, which will be carefully monitored, and discomfort from procedures like blood draws. You will be fully informed of all known risks before deciding to join, and you are free to withdraw from the study at any time without giving a reason.

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 kind of medicines are Alogliptin and Empagliflozin?

They are both medicines used to help manage type 2 diabetes by lowering blood sugar.

Why are healthy people needed for this study?

Using healthy people helps researchers see how the drugs interact without other health conditions making the results unclear.

Will I be treated for diabetes in this study?

No, this study is about understanding how the drugs interact in the body, not about treating diabetes.

What does 'fasting' mean in this study?

It means you won't be allowed to eat for a certain period before taking the study medication.

How long will this study last for me?

The exact duration for your participation will be explained by the study team, as it can vary, but these early-stage studies are usually short-term.