Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Exploratory Bioavailability of Three Formulations of Gliclazide MR Tablets 120 mg (I.R.I.S.) in Healthy Volunteers Under Fed Conditions (High Fat High Calorie Meal and Standard Meal).

This study is exploring how three different versions of a 120mg gliclazide MR tablet are absorbed into the body when healthy volunteers take them after eating. The tablets contain gliclazide, a medicine often used for diabetes, but this study doesn't involve treating any conditions. Instead, researchers want to understand how the body processes the medicine under specific conditions, like after a high-fat, high-calorie meal or a standard meal. This type of research helps pharmaceutical companies create medicines that work effectively and consistently for patients. By carefully observing how the body handles these different tablet formulations with food, they can make sure future medicines are well-designed.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Institut De Recherches Internationales Servier IRIS

Enrolment target

Start

30 Aug 2024

No medical condicion.

What is this study about?

This study is looking into how well a medicine called gliclazide is taken up by your body when it's given in different tablet forms. Specifically, it's focusing on a 120mg dose of a special 'MR' tablet, which stands for Modified Release. This means the medicine is released slowly over time, rather than all at once. The study will give healthy volunteers different versions of these tablets after they've eaten various types of meals. This helps researchers understand how food, particularly meals with different fat and calorie levels, might affect how much of the medicine gets into your bloodstream and how quickly.

The main goal of this type of research is to understand the 'bioavailability' of the drug. In simple terms, bioavailability describes how much of the medicine actually reaches its target in your body after you take it. Knowing this is very important for drug companies when they are developing new medications or improving existing ones. It ensures that the medicine will work as intended and that doctors can confidently prescribe the correct dose.

Even though gliclazide is a medicine often used to help people with diabetes control their blood sugar, this particular study isn't about treating any health condition. Instead, it's a very early-stage study, sometimes called 'Phase I', designed to gather important information about how the drug behaves in the human body. This foundational research is crucial for making sure that any future gliclazide medications are safe, effective, and absorbed properly by patients.

Key takeaways

This study is for healthy volunteers only.
It's looking at how different gliclazide tablet forms are absorbed.
Food affects how medicines are absorbed, and this study will investigate that.
Participation helps pharmaceutical companies improve medications.
It's an early-stage study, not a medical treatment.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. There is no upper age limit mentioned, so adults of any age from 18 upwards can potentially join.

This study is open to both men and women. Because this is a very early-stage study looking at how a medicine is absorbed, it's only open to healthy volunteers, meaning people without any ongoing medical conditions.

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 a healthy person with no current medical conditions?
Are you comfortable with taking an oral medication?
Are you comfortable with potentially having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be considered a healthy volunteer. This means you wouldn't have any specific medical conditions being tested or treated. You would receive different versions of the gliclazide MR 120mg tablets and have your body’s response monitored.

The study would involve careful observation of how your body processes the medicine after you've eaten particular types of meals, including a high-fat, high-calorie meal and a standard meal. This would likely involve staying at a clinic for periods of time so that researchers can take regular blood samples to measure how much of the medicine is in your system. The exact number of visits, assessments, and the full duration of your involvement isn't detailed here but would be fully explained before you agree to participate.

Potential risks and benefits

The potential benefits of taking part in a study like this include contributing to important medical research that helps develop safer and more effective medicines for future patients. While there isn't a direct personal health benefit, your participation aids scientific understanding. As with any medication, there can be potential risks or side effects from taking the gliclazide tablets, although these would be thoroughly explained to you, and you would be closely monitored by medical staff. You are always 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
Portugal

Common questions

What is gliclazide?

Gliclazide is a medicine often used to help people with type 2 diabetes control their blood sugar levels.

Why are they using healthy volunteers?

Using healthy volunteers helps researchers understand how the medicine works in the body without other health conditions affecting the results. This is common in early-stage drug development.

What does 'MR' mean in gliclazide MR tablets?

'MR' stands for Modified Release, which means the medicine is released slowly into your body over a longer period, rather than all at once.

Will this study benefit my health directly?

This particular study is not designed to improve your health directly. Its main purpose is to gather information about how the medication is absorbed, which helps develop better medicines for everyone.

What if I feel unwell during the study?

You'll be closely monitored by medical staff throughout the study, and if you feel unwell, you should tell them immediately. You always have the right to withdraw from the study.