Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

The bioavailability study of Dapagliflozin

This research is a 'bioequivalence study' focusing on a medicine called Dapagliflozin, which is used for diabetes. In simple terms, it's designed to see how much of the medicine gets into your bloodstream and how quickly. This is crucial because it helps scientists make sure that different versions or brands of the same medication deliver the same amount of active ingredient to your body. These types of studies are usually done early on, often with healthy volunteers, to ensure new medicines or generic versions are just as effective and safe as existing ones. It's a fundamental step that helps ensure medicines are consistent and reliable for patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Cinfa S.A.

Enrolment target

Start

06 Aug 2025

not applicable (submitted trial is a bioequivalence study

What is this study about?

This study is looking at a medicine called Dapagliflozin. You might know this medicine is used to treat type 2 diabetes. However, this particular study isn't about treating a condition; it's a special kind of research called a 'bioequivalence study'. Think of it as a quality control check for medicines.

So, what does 'bioequivalence' mean? It simply means the study wants to find out if different versions of the same medicine act the same way in your body. For example, if there are two versions of a Dapagliflozin tablet, this study checks if they both release the same amount of medicine into your bloodstream at the same speed. This is very important because it ensures that whether you take one brand or another, you're getting the same effective dose.

These types of studies are typically done at the very beginning of a medicine's development, often in healthy people. This helps researchers understand how the medicine behaves in the body without other health conditions getting in the way. It's a key part of making sure that medicines are safe, effective, and consistent for everyone who takes them in the future.

Key takeaways

This study is about how a diabetes medicine, Dapagliflozin, is absorbed by the body.
It's a 'bioequivalence' study, checking if different versions of the medicine work the same.
Participation often involves taking the medicine and having blood tests.
It's a very early-stage study, usually done in healthy adults.
You could help ensure medicines are safe and consistent.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are also welcome to join.

This study is open to both men and women. As it's a very early-stage study checking how a medicine works in the body, it often looks for healthy volunteers rather than people with specific health conditions. The official description doesn't mention any particular medical conditions, so it's generally open to a wide range of adults.

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 interested in helping medical research?
Are you generally healthy and don't have a lot of ongoing medical conditions?
Are you comfortable with taking a study medicine and having blood samples taken?

Answer every question to see your result.

What does participation involve?

We don’t have all the details about what would happen step-by-step for this specific study, as the summary provided is very brief. However, for a study like this, you would typically expect:

* **Screening Visit:** You’d have an initial check-up to make sure you're healthy enough to take part. This might include blood tests, a physical exam, and answering questions about your health and lifestyle. * **Dosing Visits:** You would likely need to stay at a special research clinic for one or more short periods (perhaps a day or two each time). During these stays, you would be given the study medicine, usually as a tablet. * **Assessments:** After taking the medicine, a team of nurses or doctors would regularly take blood samples over several hours to measure how much of the medicine is in your bloodstream. This is the main part of what the study is trying to find out. * **Follow-up:** There might be a final check-up a few days after you've completed the dosing to make sure you're feeling well.

The entire study usually lasts from a few days to a few weeks, depending on how many different times you need to take the medicine and be observed.

Potential risks and benefits

The main benefit of taking part in this type of study is helping advance medical knowledge and ensure that medicines are consistent and safe for everyone. You might also receive payment for your time and inconvenience. However, there are potential risks, such as side effects from the study medicine, even if you are healthy. These could include mild symptoms like headaches or feeling sick, or more rarely, more serious reactions. There's also the discomfort of blood tests. Remember, your participation is completely voluntary, and you have the right to withdraw from 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
Czechia

Common questions

What is Dapagliflozin?

Dapagliflozin is a medicine commonly used to help manage type 2 diabetes by helping the body remove excess sugar, but this study isn't about treating diabetes directly.

What does 'bioequivalence' mean?

It means the study is checking if different versions of the same medicine work exactly the same way in your body, delivering the same amount of medicine at the same speed.