Randomised, crossover bioequivalence clinical trial of linagliptin/metformin 2.5 mg/1000 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fed conditions.
This study is looking at a new version of a combination medicine for diabetes, called linagliptin/metformin (2.5 mg/1000 mg). The main goal is to find out if this new tablet works in the body the same way as the original medicine, even after someone has eaten. To do this, healthy adult volunteers will take a single dose of the new tablet. Researchers will then check how the medicine is absorbed and used by the body. This kind of study helps ensure that new versions of existing medicines are just as effective and safe as the ones already in use, offering more choices for patients in the future.
At a glance
What is this study about?
This study is about a medicine that helps people with diabetes. It's a combination of two drugs, linagliptin and metformin, and it comes as a tablet. When a pharmaceutical company creates a new version of an existing medicine, like a tablet that's made slightly differently or by a new manufacturer, they need to prove it works just as well as the original.
This particular study is a "bioequivalence" study. That's a fancy word meaning "does it work the same way in the body?" Researchers want to check if the new version of the linagliptin/metformin tablet delivers the medicine into your bloodstream in the same amount and at the same speed as the original. They're making sure that if you take this new tablet, your body will use the medicine in exactly the same way.
To make sure their results are trustworthy, they'll give a single dose of the tablet to healthy adult volunteers after they've eaten a meal. Studying it in healthy people helps them understand how the medicine behaves without other health conditions complicating the results. This research is a really important step before new versions of medicines can be approved for people who need them, ensuring patients always get effective and reliable treatments.
Key takeaways
- This study tests a new version of a diabetes medicine.
- It's checking if the new tablet works just like the original one.
- Healthy adult volunteers are needed for this testing.
- You'll take a single dose after a meal, and blood samples will be taken.
- It's a way to help ensure new medicines are safe and effective.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Because this study is testing how a new medicine works in the body, it's looking for people who are generally healthy. This means you shouldn't have any serious ongoing health problems.
They will check your health carefully to make sure it's safe for you to take part. This typically involves a health check-up, blood tests, and reviewing your medical history.
- Are you 18 years old or older?
- Are you generally healthy?
- Are you Male or Female?
- Are you willing to follow study instructions carefully?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be one of the healthy volunteers helping us. You'll visit the study clinic multiple times. During these visits, you will receive a single dose of the study medicine after eating a meal. This is done on separate occasions, as it's a "crossover" study, meaning you might get different versions of the medicine at different times, though the main goal is to compare the new tablet against itself or a standard version.
Nurses and doctors will take blood samples regularly after you take the medicine to see how it's absorbed and leaves your body. This will usually involve a small tube (cannula) placed in your arm for easier blood draws. You'll be carefully monitored for a number of hours after each dose. You'll also have check-ups to make sure you're well throughout the study. The total time you'll be involved in the study, from your first check-up to your last visit, will be explained fully by the study team.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is linagliptin/metformin for?
It's a combination medicine typically used to help manage type 2 diabetes by helping the body control blood sugar levels.
Why are healthy people needed for this study if it's for diabetes?
Healthy volunteers allow researchers to see how the medicine works in the body without other health conditions affecting the results, giving a clearer picture of how it's absorbed and processed.
What does 'single oral dose' mean?
It means you will only take the study medicine one time on each study day, rather than taking it regularly over a longer period.
Will I get paid for taking part?
Most studies like this offer some payment for your time, travel, and inconvenience. The study team will give you all the details.
Can I stop taking part if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without having to explain why.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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