Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of dapagliflozin/metformin

This research study, called a bioequivalence trial, is designed for healthy adult volunteers. Its main goal is to compare two different versions of a medicine that combines dapagliflozin and metformin. These medicines are often used to help manage conditions like type 2 diabetes. We want to see if both versions are absorbed into the body in the same way and at the same speed. This type of study is important to make sure that different versions of a medicine have the same effects. It's a very early-stage study, often called Phase I, focusing on understanding how the medicine behaves in the human body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

06 Aug 2025

Healthy volunteers

What is this study about?

This study is all about understanding how medicines work inside your body. Sometimes, there are different versions of the same medicine. While they contain the same active ingredients, they might be made slightly differently. This research aims to check if two specific versions of a combination medicine, dapagliflozin and metformin, act in the same way when taken by healthy people.

The main purpose of this study is to compare how quickly and how much of each medicine gets into your bloodstream. This is called 'bioequivalence'. If two medicines are 'bioequivalent', it means they can be expected to have the same effects in the body. This is crucial for ensuring that different brands or types of the same medication are equally safe and effective for patients.

This is a 'Phase I' study, which means it's one of the first steps in testing a medicine in humans. These studies are typically done with healthy volunteers to understand the basic way the medicine is handled by the body, rather than treating a specific illness. It helps scientists gather important information before the medicine can be studied in larger groups of patients.

Key takeaways

This study compares two versions of dapagliflozin/metformin medicine.
It's for healthy adult volunteers, aged 18 and over.
The main goal is to see if the medicines are absorbed similarly by the body.
Participation involves taking the medicine and having blood tests.
You are contributing to understanding how medicines work safely.

Who may be eligible?

To join this study, you need to be a healthy adult, aged 18 years or older. Both men and women are welcome to take part.

Because this study focuses on healthy people, you won't be able to join if you have certain health conditions or are taking particular medications. The study team will carefully check your health to make sure it's safe for you to participate.

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 willing to take the study medication?
Are you comfortable with having blood tests?
Are you able to attend all study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given two different versions of the dapagliflozin/metformin medicine, usually at different times. The study team will take blood samples at specific moments to measure how much of the medicine is in your body. You might also have other check-ups like blood pressure readings and general health checks. The total time you'd be involved in the study, including any follow-up appointments, would be explained in detail by the study team.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science and helping to ensure new or generic medicines are safe and effective for everyone. As with any medicine, there's always a chance of side effects, but these studies are carefully designed to minimise risks. You will be closely monitored by medical staff throughout the study. Remember, 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
Spain

Common questions

What does 'bioequivalence' mean?

It means the study is checking if two different versions of a medicine behave in the same way in your body, like getting into your bloodstream at the same speed and amount.

Why is this study only for healthy volunteers?

Early-stage studies often use healthy volunteers to understand how the medicine works in a typical body without other health conditions making it complicated.

Will I receive treatment for an illness?

No, this study is about checking how the medicine is absorbed, not about treating an illness. You should be healthy to join.

What kind of tests will I have?

You'll most likely have blood tests to measure the medicine levels, and regular health checks like blood pressure.

Will I get paid for taking part?

Some studies offer payment for your time and inconvenience, but this varies. The study team will tell you about any compensation.