Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of One Tablet of Gliclazide MR 120 mg (S005190) and Two Tablets of Gliclazide MR 60 mg (Diamicron® MR) in Healthy Participants under Fed Conditions.

This study, called a bioequivalence study, is looking at a new version of a common diabetes medicine called gliclazide MR. It aims to see if one 120mg tablet of this new medicine is absorbed and handled by the body in the same way as two separate 60mg tablets of the currently available Diamicron® MR. This is important to make sure that the new tablet works just as effectively and safely as the older one. Healthy adult volunteers will be taking part, and the medicine will be given when participants have eaten recently. The study helps regulators approve new versions of medicines, giving patients more treatment options while ensuring quality and effectiveness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Institut De Recherches Internationales Servier IRIS

Enrolment target

Start

07 Mar 2025

No medical condition.

What is this study about?

This clinical trial is designed to compare two different forms of a medicine called gliclazide MR. Gliclazide is often used to help people with type 2 diabetes manage their blood sugar levels. The "MR" stands for "Modified Release," meaning the medicine is released slowly into your body over time.

The main goal of this study is to see if a single, new 120mg tablet of gliclazide MR acts the same way in the body as two 60mg tablets of an existing product called Diamicron® MR. This type of study is called a "bioequivalence study." It doesn't test if the medicine works to treat a disease, but rather if the body absorbs and processes the two different tablet forms in the same way. This is crucial for ensuring that a new version of a medicine is just as good and as safe as an older, established one.

Researchers will observe how much of the medicine gets into the bloodstream and how quickly, to confirm that the new 120mg tablet delivers the same amount of medicine at the same rate as the two 60mg tablets. This information is vital for regulatory bodies to approve new medicines, ensuring that patients have access to effective treatments, potentially in more convenient forms.

Key takeaways

Compares a new 120mg gliclazide tablet to two older 60mg tablets.
Aims to ensure new medicine acts the same as existing one.
For healthy adults aged 18 and over.
Involves taking medicine after food and having blood tests.
Helps make sure new medicines are effective and safe.

Who may be eligible?

This study is looking for healthy adults to take part. This means you shouldn't have any significant medical conditions or be taking any regular medications that could affect the study results.

You must be at least 18 years old to participate. There isn't an upper age limit mentioned, so older adults could also be considered if they are otherwise healthy.

Both men and women are welcome to join this study. The researchers will assess your overall 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 generally healthy with no serious medical conditions?
Are you 18 years old or older?
Are you not currently taking regular prescription medications?
Are you willing to have blood samples taken?
Are you comfortable potentially taking an investigational medicine?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would be given either the new 120mg gliclazide MR tablet or the two 60mg Diamicron® MR tablets, usually after a meal, to see how your body handles it. This is normal practice to understand how medicines work when taken with food.

Throughout the study, you would have blood samples taken at specific times to measure the levels of the medicine in your body. You might also have other check-ups to monitor your general health. The total duration of your involvement isn't specified, but bioequivalence studies typically involve a screening visit, one or more dosing periods (often with washout periods in between), and follow-up checks. You will be fully informed about the exact schedule before you agree to participate.

Potential risks and benefits

The potential benefits of participating aren't directly to your health, as this study is for healthy volunteers and not a treatment. Your participation helps advance medical science, potentially leading to more convenient medication options for people with diabetes. Potential risks are generally low in bioequivalence studies but could include discomfort from blood draws, temporary side effects from the medication (even in healthy people, though gliclazide can lower blood sugar, monitoring would be in place), and the time commitment. You have the right to withdraw from the study at any time, for any reason, without consequences.

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

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how the medicine works in the body without other health conditions interfering with the results.

What is 'bioequivalence'?

It means checking if two different versions of a medicine act the same way in your body, delivering the same amount of medicine at the same speed.

Will I be given medication regularly?

You will be given the study medication during specific dosing periods, but it's not a long-term treatment as you are a healthy volunteer.

What does 'under fed conditions' mean?

It means you will take the medicine after you have eaten a meal, as this can sometimes affect how your body absorbs medication.

Is this medicine for diabetes?

Yes, gliclazide is a medicine used to treat type 2 diabetes. However, in this study, it's being tested in healthy people to compare different tablet forms, not to treat diabetes.