Multiple-Dose Study on the Bioequivalence of One Tablet of Gliclazide MR 120 mg (S005190) and Two Tablets of Gliclazide MR 60 mg (Diaprel® MR) in Healthy Participants under Fed Conditions.
This research is looking at a medicine called Gliclazide MR, which is used to treat type 2 diabetes. We are comparing two different ways of giving this medicine to healthy people. One way is a single 120mg tablet, and the other is two 60mg tablets (like Diaprel® MR). The main goal is to check if these two ways of taking the medicine have the same effect on the body when someone has eaten food. This type of study, called a bioequivalence study, helps ensure that different versions or doses of a medicine work in the same way. It's a very early stage of research, usually done in healthy people to understand how the medicine behaves.
At a glance
What is this study about?
This study is all about a medicine called Gliclazide MR, which is often prescribed for people with type 2 diabetes. While this medicine is used for diabetes, this particular study is being carried out in healthy volunteers, not people with diabetes. The main purpose is to carefully compare two different doses of this medicine. We want to see if taking one tablet of 120 milligrams (mg) works in the same way as taking two tablets of 60mg each (which add up to 120mg). This comparison is important to make sure that if a doctor changes your dose or switches you from one strength of tablet to another, the medicine will still have the same, expected effect on your body.
Think of it like making a cup of tea: does using one large teabag give you the same strength and taste as using two smaller teabags? This study uses a similar idea to check the medicine. They will be looking at how the medicine is absorbed into the bloodstream when you take it with food. This information is really important for pharmaceutical companies and doctors to ensure that medicines are consistent and safe for patients.
This type of study is called a 'bioequivalence study' and it's a standard and necessary step in developing and approving medicines. It helps confirm that different forms or doses of a drug are medically equivalent, meaning they deliver the same amount of active ingredient to your body at the same speed. This ensures that patients receive a consistent treatment, regardless of the specific tablet they are prescribed.
Key takeaways
- This study compares two different tablet strengths of Gliclazide MR.
- It aims to see if one 120mg tablet works the same as two 60mg tablets.
- Healthy adults aged 18 and over can take part.
- The medicine will be taken with food, and blood tests will be used to track it.
- This research helps ensure diabetes medicines are consistent and safe for patients.
Who may be eligible?
To be considered for this study, you need to be a healthy adult. This means you shouldn't have any significant ongoing medical conditions. The study is open to both men and women.
You must be at least 18 years old to take part. There isn't an upper age limit mentioned, so older adults could potentially participate as long as they are generally healthy.
It's important to remember that 'healthy' means different things to different people. The study team will do a thorough medical check-up to make sure you're suitable. They will ask detailed questions about your health and may take blood or urine samples to confirm you meet all the health requirements.
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 with no serious medical conditions?
- Are you comfortable with taking study medication and having regular blood tests?
- Are you available for multiple clinic visits over a period of time?
What does participation involve?
If you decide to take part, you would be given the study medicine (either one 120mg tablet or two 60mg tablets of Gliclazide MR) on different occasions. These would be taken with food, as the study specifically looks at how the medicine works under 'fed conditions'. You would likely spend some time at the clinic after taking the medicine so the researchers can take regular blood samples to measure how the drug levels change in your body over time.
Because this is a 'multiple-dose' study, it means you would likely take the medicine more than once over a period of time, perhaps on several separate days or during several clinic visits. This helps the researchers understand the medicine's effects over a longer period, rather than just from a single dose.
Throughout your participation, you would have regular assessments, including physical examinations, blood tests, and perhaps other health checks to monitor your wellbeing. The total length of your involvement, including all visits and follow-up, would be fully explained by the study team before you agree to take part.
Potential risks and benefits
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Common questions
What is Gliclazide MR?
It's a medicine commonly used to help manage type 2 diabetes by helping the body produce more insulin.
Why is this study done in healthy people, not people with diabetes?
Early studies like this are often done in healthy volunteers to understand how the medicine behaves in the body without other health conditions making it complicated.
Will I get paid for taking part?
Most studies of this type offer some financial compensation for your time and inconvenience. The study team will provide full details.
Can I leave the study if I change my mind?
Yes, you are completely free to leave the study at any time, for any reason, and it won't affect your future medical care.
What does 'fed conditions' mean?
It means you will take the medicine after having eaten a meal, so researchers can see how food affects its absorption.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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