Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of dapagliflozin/metformin

This study is a bioequivalence trial, which means we are comparing two versions of a combined medicine called dapagliflozin/metformin. This medicine is often used to treat type 2 diabetes. We are giving these medicines to healthy volunteers to see if the body uses them in the same way. It's like checking if two different brands of the same product deliver the same effect. This kind of research is important to ensure that new medicines are just as effective and safe as the original ones, giving patients reliable treatment options. It helps regulators approve new medicines for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

23 May 2025

Healthy volunteers

What is this study about?

This is a special type of study called a 'bioequivalence' trial. In simple terms, it means we're comparing two different versions of the same medicine. Imagine you have two different brands of a painkiller; this study wants to find out if your body handles them in the exact same way and if they deliver the same amount of medicine to your bloodstream.

The medicine we're looking at is a combination of dapagliflozin and metformin. This particular medicine is commonly used to help people with type 2 diabetes manage their blood sugar levels. However, for this study, we're asking healthy volunteers to take part, not people with diabetes.

The main goal is to be sure that if a new version of this medicine is made, it works just as well and is delivered to the body in the same way as the established version. This research is a really important step in developing new medicines. It helps ensure that any new medicine that comes out is reliable and effective for patients.

Key takeaways

Compares two versions of a diabetes medicine (dapagliflozin/metformin).
Aims to check if they work the same way in the body.
Looking for healthy volunteers aged 18 and over.
Involves clinic visits and blood tests.
Helps ensure new medicines are safe and effective.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy men and women aged 18 and over. There is no upper age limit, meaning older adults are welcome to take part too.

To be considered healthy, you would generally not have any serious long-term health conditions or be taking regular prescription medicines. Your health will be checked by a study doctor 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?
Do you consider yourself generally healthy?
Do you not have any major long-term health conditions?
Are you not currently taking regular prescription medicines (besides common contraception)?
Are you willing to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you take part, you will visit the study clinic several times. During these visits, you'll receive doses of the study medicine. We will then take blood samples at different times to measure how much of the medicine is in your body. We'll also monitor your general health, including things like your heart rate and blood pressure. You might have to stay at the clinic for a short period after taking the medicine for closer observation. The total time you'll be involved in the study will be explained to you in detail.

Potential risks and benefits

The main benefit of taking part is contributing to medical science and helping to ensure new medicines are safe and effective for future patients. You might also receive some payment for your time and travel. Potential risks usually involve mild side effects from the medicine, such as stomach upset or headaches, as well as discomfort from blood draws. However, your health will be closely monitored by medical staff. You are free 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.

—
Unverified
Spain

Common questions

What is 'bioequivalence'?

It means we're checking if two versions of the same medicine work exactly the same way in your body.

Why are healthy people getting diabetes medicine?

We use healthy volunteers to focus only on how the body handles the medicine, without other health conditions making it complicated.

Will I get paid for taking part?

Often, studies like this offer payment for your time, travel, and inconvenience. Specific details will be provided.

What side effects might I experience?

Common drug side effects like stomach upset or headaches are possible, but you'll be told all known risks before you agree to take part.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.