Bioequivalence of One Tablet of Gliclazide MR 90 mg (S005190) and One and a Half Tablets of Gliclazide MR 60 mg (Diamicron® MR) in Healthy Participants under Fed Conditions.
This research is a 'bioequivalence' study looking at two versions of a medicine called Gliclazide MR, which is used to treat type 2 diabetes. We are comparing a single 90mg tablet to one and a half 60mg tablets to see if they deliver the medicine into the body in the same way. This is important to make sure new forms of a medicine work as expected. Healthy adults will take these medicines after eating, and doctors will check how their bodies handle the medicine. This type of study is a standard part of developing new medicines to ensure they are safe and effective for patients.
At a glance
What is this study about?
Imagine you have a new jigsaw puzzle piece, and you want to make sure it fits perfectly with the other pieces. That's a bit like what this study is doing with medicine. We're looking at a medicine called Gliclazide MR, which helps people with type 2 diabetes manage their blood sugar. This study is like a 'checking' process to see if two different ways of giving this medicine work in the same way.
Specifically, we're comparing a single 90mg tablet of Gliclazide MR with taking one and a half of the 60mg tablets. It’s important for medicines to be absorbed into the body at a similar rate and amount, no matter how they are packaged or dosed. This is known as 'bioequivalence'. If two different versions are 'bioequivalent', it means they can be used interchangeably, giving doctors and patients more options.
So, why does this matter? Well, for medicines like Gliclazide MR, knowing that different tablet strengths deliver the same amount of medicine to the body in a similar way is crucial. It helps ensure that patients always get the correct and consistent effect, contributing to their health and well-being. This study helps answer important questions about how medicines are handled by our bodies, especially after we've eaten, which can sometimes change how medicine is absorbed.
Key takeaways
- This study compares two strengths of Gliclazide MR tablets (90mg vs 60mg) in healthy adults.
- The goal is to see if they both deliver the medicine to the body in the same way (bioequivalence).
- Participants will take the medicine after eating and have regular blood tests.
- It helps ensure future diabetes treatments are safe and work as expected.
- No medical conditions are required; participants must be healthy adults (18+ years old).
Who may be eligible?
This study is looking for healthy adults to take part. This means we are not looking for people who have any existing medical conditions or are currently taking medication for an illness. The aim is to understand how the medicine works in a healthy body before it's given to people with diabetes.
To be considered, you need to be at least 18 years old. There's no upper age limit mentioned, so as long as you're an adult and otherwise healthy, you might be suitable. Both men and women are welcome to participate in this study. The medical team will check your health carefully to ensure it's safe for you to take part.
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 and don't have any ongoing medical conditions?
- Are you not currently taking any regular prescription medication (excluding perhaps birth control)?
- Are you able to attend several clinic visits or stays?
- Are you comfortable with having blood samples taken periodically?
What does participation involve?
If you decide to take part, you'll be given either one 90mg Gliclazide MR tablet or one and a half 60mg Gliclazide MR tablets on different occasions. You'll take these after eating a meal. You will need to visit the study clinic several times for these doses and to have blood samples taken regularly to measure how the medicine is absorbed into your body. Doctors and nurses will monitor you closely throughout your time in the study.
There might be a screening visit to check your health before you can join. The total duration of your involvement could span several days or weeks, typically involving short stays or multiple visits to the clinic, but the exact schedule will be explained in detail. You'll be told about any restrictions on food, drinks, or other medicines you need to follow during the study period.
Potential risks and benefits
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Common questions
What is Gliclazide MR used for?
Gliclazide MR is a medicine typically used to help people with type 2 diabetes control their blood sugar levels.
Why are you studying healthy people if it's a diabetes medicine?
Studying healthy volunteers helps us understand how the medicine is absorbed and handled by the body without the complications of an existing health condition.
What does 'bioequivalence' mean?
'Bioequivalence' means that two different versions of a medicine deliver the same amount of the active drug to the body in a similar way and at a similar speed.
Will I get diabetes from taking this medicine?
No, taking Gliclazide MR during this short study in healthy individuals is not expected to cause diabetes. Your blood sugar will be carefully monitored.
Will I be paid for taking part?
Many healthy volunteer studies offer compensation for your time and inconvenience. This will be explained in full by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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