Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of dapagliflozin.

This study is a bioequivalence trial, which means it compares two different versions of a medicine called dapagliflozin. Dapagliflozin is typically used to help manage type 2 diabetes. The aim is to see if both versions are absorbed and used by the body in the same way. This is an early stage study, meaning it's done before a new medicine is widely available, and it involves healthy volunteers. By comparing how the body handles these medicines, researchers can make sure that any new generic or alternative version works just as effectively as the original. This helps ensure patients get consistent treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

24 Jun 2024

Healthy volunteers

What is this study about?

This study is a bit like checking if two different brands of a popular drink taste exactly the same and have the same effect. In this case, we're looking at two versions of a medicine called dapagliflozin. Dapagliflozin is a drug that helps people with type 2 diabetes manage their blood sugar levels. When a new version of a medicine is made, perhaps by a different manufacturer or in a slightly different way (like a tablet versus a liquid), doctors need to be sure it works just as well and is just as safe as the original.

This type of research is called a 'bioequivalence study'. It's focused on understanding how the medicine gets into your bloodstream and how your body processes it. The goal is to show that the new version of the medicine behaves in the human body in the same way as an already approved version. This is really important because it ensures that patients will receive the same benefits and experience the same effects, regardless of which version of the medicine they take.

Because this is an early stage study, it involves healthy volunteers. This is often done to get a clear picture of how the medicine acts in the body without the complications of other health conditions. If the two versions are found to be 'bioequivalent' – meaning they work similarly – then it helps pave the way for the new version to potentially be used more widely, offering more options for patients.

Key takeaways

Tests two different versions of a diabetes medicine (dapagliflozin).
Compares how the body absorbs and uses each version.
Aims to ensure new versions work the same as existing ones.
Involves healthy adult volunteers (aged 18+).
It's an early-stage study to gather important information.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 years or older – there's no upper age limit.

The study is open to both men and women. Being 'healthy' usually means you don't have any major ongoing health problems and aren't taking certain medications that could interfere with the study results.

The researchers will do some checks to make sure you're healthy enough to take part. This might include a medical history, a physical exam, and some blood tests. They'll explain all of this to you clearly.

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?
Are you able to follow study instructions carefully?
Are you available for study visits and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicines (dapagliflozin) at specific times. This involves taking different versions of the medicine, usually separated by a 'washout' period where you don't take any medicine. You would likely need to stay at a research clinic for a period after taking the medicine so that researchers can take regular blood samples to measure how the medicine is absorbed and leaves your body. You might also have other checks like blood pressure measurements. 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

Participating in research always comes with potential risks and benefits. A potential benefit could be contributing to medical knowledge that might help future patients. You might also receive free health checks during the study. Potential risks could include side effects from the medicine, the discomfort of blood tests, or the time commitment required. However, the study team will monitor you closely for any issues. Please remember, taking part is completely voluntary. 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 is dapagliflozin used for?

Dapagliflozin is a medicine commonly prescribed to help people with type 2 diabetes manage their blood sugar levels.

What does 'bioequivalence' mean?

It means the study is comparing two versions of the same medicine to see if they are absorbed and work in the body in the same way.

Will I get personalised medical advice or treatment in this study?

No, this study is for research purposes only and does not involve providing personalised medical advice or treatment for any health conditions you might have.

Do I have to be sick to join this study?

No, this specific study is looking for healthy volunteers, meaning people who do not have any significant health problems.

What will happen if I change my mind after joining?

You can leave the study at any time, for any reason, without needing to explain why.