Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Exploratory Bioavailability of Two Formulations of Gliclazide MR Tablets 120 mg (I.R.I.S.) in Healthy Volunteers Under Fed and Fasting Conditions.

This study is investigating two different types of a diabetes medication called gliclazide MR, specifically a 120 mg dose. We are looking at how well each version is absorbed into the body when taken by healthy volunteers. The study will compare how these medications work when people have eaten and when they haven't. This research is a very early stage of testing, often called Phase 1. The main goal is to understand how the body handles these medicines under different conditions, which helps scientists develop effective treatments for people with type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Institut De Recherches Internationales Servier IRIS

Enrolment target

Start

03 Nov 2023

Type 2 diabetes mellitus

What is this study about?

This study is focused on a medicine called gliclazide MR, which is used to help manage type 2 diabetes. Specifically, we're comparing two slightly different versions of this medicine, both at a 120 mg dose. Our main goal is to understand how the body absorbs and uses each of these versions.

Think of it like this: when you take a medicine, your body needs to break it down and absorb it into your bloodstream for it to work. Sometimes, the way a medicine is made can affect how quickly or how much of it gets absorbed. This study aims to see if there are any differences between these two versions of gliclazide MR.

We're also looking at whether eating food before taking the medicine makes a difference to how it's absorbed. Sometimes food can change how a treatment works, so it's important to find this out. This kind of research is a very early step in testing new medicines, often done in healthy people first to make sure it's safe and to understand what happens to the medicine inside the body.

Key takeaways

This study compares two versions of a diabetes medicine called gliclazide MR.
It checks how food affects the absorption of these medicines in healthy adults.
Participants will take the medicine both after eating and on an empty stomach.
Blood samples will be taken to measure medicine levels in the body.
This is an early-stage study to gather important information for future treatments.

Who may be eligible?

To join this study, participants need to be healthy adults. You can be a man or a woman, and you need to be at least 18 years old. There isn't an upper age limit for taking part.

The study is specifically looking for healthy volunteers, meaning people who do not have any significant ongoing health conditions, especially not type 2 diabetes, even though the medicine is for diabetes. This is so researchers can see exactly how the medicine is absorbed without other health problems affecting the results.

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 healthy, without any major ongoing medical conditions?
Are you able to commit to the study visits and procedures, including blood tests?
Are you comfortable potentially staying overnight at a study clinic?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be given one of the two gliclazide MR 120 mg medicines to take. You will have multiple study visits. On some occasions, you will take the medicine after eating a meal, and on other occasions, you will take it on an empty stomach (fasting). Researchers will need to take blood samples regularly after you take the medicine to measure how much of it is in your system. You might stay at a special research clinic for several days at a time during these different parts of the study. The total duration of your participation, including all visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it contributes to important scientific knowledge about medicines, which can help develop better treatments for people with type 2 diabetes in the future. As this is an early-stage study in healthy volunteers, there are no direct health benefits to you personally from taking the diabetes medicine. Possible risks include discomfort from blood draws, and potential side effects from the gliclazide MR, although it's generally well-tolerated. All procedures will be explained thoroughly, and you will have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

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

What is gliclazide MR for?

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

Why is this study using healthy volunteers?

Using healthy volunteers helps researchers understand how the medicine is absorbed and processed by the body without other health conditions affecting the results.

What does 'fed and fasting conditions' mean?

It means you'll take the medicine on some occasions after you've eaten a meal, and on other occasions when you haven't eaten for a certain amount of time (fasting).

Will I have to stay overnight for the study?

It's likely that parts of the study will require you to stay at a research clinic for short periods, possibly overnight, to monitor how the medicine works.

What is 'Phase 1' research?

Phase 1 is the earliest stage of human testing for a new medicine. It mainly focuses on safety and how the body handles the drug.