Bioequivalence of One Tablet of Gliclazide MR 120 mg (S005190) and Two Tablets of Gliclazide MR 60 mg (Diamicron® MR) in Healthy Participants under Fasting Conditions.
This research study is about a medicine called Gliclazide MR, which is used to treat diabetes. The main goal is to check if a new 120mg version of this medicine works in exactly the same way in the body as two separate 60mg tablets of the current version. This is important to make sure that patients get the correct amount of medicine, regardless of the tablet strength they take. The study will involve healthy people who don't have any medical conditions. Participants will take the medicine after fasting, which means not eating for a certain period. This type of study is called a bioequivalence study, and it's a routine step in developing new medicines or new versions of existing ones, ensuring they are safe and effective.
At a glance
What is this study about?
This study is looking at a medicine called Gliclazide MR. You might know that medicines often come in different strengths, like 60mg or 120mg. When a company makes a new strength of an existing medicine, or perhaps changes how it's made slightly, they need to check if your body uses it in exactly the same way as the original or equivalent strength. This is really important to make sure that if a doctor prescribes you a 120mg tablet, it works the same as if you took two 60mg tablets.
In this particular study, researchers want to compare one 120mg Gliclazide MR tablet with two 60mg Gliclazide MR tablets. They want to see if the amount of medicine that gets into your bloodstream and how long it stays there is the same for both options. This is a standard and very necessary step in developing medicines, making sure they are safe, reliable, and effective for patients.
This type of study is called a 'bioequivalence' study. 'Bio' relates to the body, and 'equivalence' means being equal or the same. So, they are checking if the new medicine (or new strength) is equally available to the body compared to another version. They do this by giving the medicine to healthy volunteers and taking blood samples over time to measure the medicine levels. This provides important information to ensure that patients can confidently switch between different tablet strengths if their doctor recommends it.
Key takeaways
- This study compares different strengths of a diabetes medicine called Gliclazide MR.
- It aims to make sure a 120mg tablet works the same as two 60mg tablets.
- Healthy adults (18+) are needed to take part.
- You'll take the medicine after not eating and have blood samples taken.
- It's a common type of study to ensure medicine safety and effectiveness.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for healthy adults to take part. This means you shouldn't have any current medical conditions or be taking regular medicines for any illness. The researchers want to make sure that any effects they see from the medicine are purely due to the study drug and not complicated by other health issues.
You would need to be at least 18 years old to join this study. There's no upper age limit mentioned, so older adults could also be considered, as long as they are generally healthy. Both men and women are welcome 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 18 years old or older?
- Are you generally healthy with no current medical conditions?
- Are you not currently taking any regular prescription medications?
- Are you able to follow specific instructions, like fasting?
- Are you available for multiple clinic visits, potentially over several days?
What does participation involve?
If you decide to take part in this study, you would be asked to come to a special clinic or research unit. During these visits, nurses or doctors would give you either one 120mg Gliclazide MR tablet, or two 60mg Gliclazide MR tablets. You would take this medicine after not eating for a certain period, which is called 'fasting'. This helps the researchers understand how the medicine is absorbed when there's no food in your stomach.
After you take the medicine, you will need to stay at the clinic for several hours, and maybe even overnight for some parts of the study. During this time, the medical staff will take regular small blood samples from you. This allows them to measure how much of the medicine is in your bloodstream at different times. They will also check your blood pressure, heart rate, and ask about any side effects you might be feeling. The total duration of your participation, including all visits and follow-up, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is Gliclazide MR?
Gliclazide MR is a medicine primarily used to help people with type 2 diabetes manage their blood sugar levels.
Why do they need healthy people for this study?
Using healthy people helps researchers clearly see how the medicine works in the body without other health conditions making the results unclear.
What does 'fasting conditions' mean?
It means you won't eat anything for a certain number of hours before taking the medicine in the study. You might be able to drink water.
Will I get paid for taking part?
Most bioequivalence studies offer payment to volunteers for their time and travel. This will be confirmed by the study staff.
Will this study help me personally?
While it won't directly improve your health, your participation helps ensure medicines are safe and effective for all patients, which is a valuable contribution.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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