Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

This study is investigating a potential interaction between two medicines commonly used to treat type 2 diabetes: empagliflozin (often known by brand names like Jardiance) and alogliptin (often known by brand names like Vipidia). Even though participants in this study are healthy, the aim is to understand how these medicines behave in the body when taken at the same time. This helps doctors know what to expect if they prescribe both to patients with diabetes. The study will look at how the medicines are absorbed, distributed, and removed from the body to make sure they work safely and effectively together.

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?

This study is looking into how two different medications, empagliflozin and alogliptin, interact when someone takes them at the same time. These medicines are usually prescribed to help people with type 2 diabetes manage their blood sugar levels. Scientists want to understand if taking both together changes how they work or how they are handled by the body.

Even though people with diabetes would usually take these medicines, this particular study is recruiting healthy adult volunteers. This is typical for an early-stage study, as it helps researchers understand the basic behaviour of the drugs without other health conditions making it complicated.

The information gathered from this study is very important. It helps doctors make informed decisions about prescribing these medications together, ensuring that patients receive the safest and most effective treatment for their diabetes. By understanding any interactions, healthcare professionals can better tailor treatments and prevent potential problems.

Key takeaways

This study investigates how two diabetes medicines interact when taken together.
It involves healthy adult volunteers, not people with diabetes.
The aim is to ensure the medications are safe and effective when combined.
Participation contributes to important medical knowledge.
You'll need to follow specific instructions, including fasting.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 years or older. This study is open to both men and women.

Because this is a study about how medicines interact, you won't have any specific medical conditions that might affect how your body handles the drugs. The researchers are looking for people who are otherwise well.

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 over?
Are you generally healthy with no significant medical conditions?
Are you willing to follow specific study instructions, including fasting?
Are you aware this study is for research into drug interaction, not for treating a condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given both empagliflozin and alogliptin, likely starting with one and then adding the other. You'll need to follow specific instructions, including taking the medications after not eating for a certain period (fasting).

The study will involve several visits to a clinic where researchers will take blood samples and perform other simple checks to see how your body is processing the medicines. The exact number of visits, tests, and the total duration isn't specified here, but it would typically involve several days of close monitoring.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, the main benefit is contributing to medical knowledge that can help future patients with diabetes. There's no direct health benefit to you as a healthy participant. Potential risks could include mild side effects from the medications, discomfort from blood tests, or inconvenience from the clinic visits. You will be closely monitored by medical staff, and you are free to withdraw from the study at any time 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.

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Unverified
Portugal

Common questions

What kind of medications are empagliflozin and alogliptin?

They are both medicines primarily used to help people with type 2 diabetes manage their blood sugar levels.

Why is this study looking at healthy people, not people with diabetes?

Early studies often use healthy volunteers to understand how a drug works in the body without other health conditions making the results harder to interpret.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain period before taking the medication, as food can affect how medicines are absorbed.

Will I get diabetes from taking these medications?

No, you will be taking a short course of these medications under medical supervision. They do not cause diabetes.

What is the 'Human Pharmacology (Phase I)' phase?

It's the very first stage where a medicine is tested in people. The main goal is to check its safety and how it is handled by the body, rather than treating a disease.