Randomized, open-label, single-dose, two-period, cross-over, bioequivalence study comparing Linagliptin 5 mg film-coated tablets (Vipharm S.A.) to Trajenta® 5 mg film-coated tablets (Boehringer Ingelheim) in healthy volunteers under fasting conditions.
This study is looking at a new version of a tablet called Linagliptin, which is used to help manage type 2 diabetes. We want to make sure this new version works in the same way as an existing tablet called Trajenta®. To do this, we're asking healthy adult volunteers to take part. They will be asked to fast (not eat) for a period before taking each tablet. Over two separate periods, each participant will receive one dose of the new Linagliptin tablet and one dose of the Trajenta® tablet, allowing us to compare how their bodies handle each one. This type of study, called a 'bioequivalence study', is an important first step to ensure new medicines are safe and effective.
At a glance
What is this study about?
Imagine you have two different brands of a common household item, like pain relief tablets. Even though they contain the same active ingredient, you might wonder if they work exactly the same way. This study is similar, but it's for a medicine called Linagliptin, which is used to treat type 2 diabetes.
Researchers are comparing a new version of Linagliptin tablets, made by a company called Vipharm, with an existing one called Trajenta®, made by Boehringer Ingelheim. The main goal is to see if the new Linagliptin tablet is 'bioequivalent' to Trajenta®. This means checking if the new tablet delivers the medicine into the body at the same speed and to the same extent as the existing one. If they are bioequivalent, it means the new tablet should work just as effectively and safely as the established one.
This kind of study, often called a Phase I bioequivalence study, is a very early but crucial step in developing new medicines. It helps ensure that new versions of drugs are reliable before they can be considered for wider use. It's not about testing the drug's ability to treat diabetes directly in this study, but rather about how the body handles the medicine itself.
Key takeaways
- New diabetes tablet being compared to an existing one.
- Study checks if new tablet works just as well.
- Healthy adults (18+) can take part.
- Involves fasting and taking two different tablets.
- Blood samples used to track medicine levels.
Who may be eligible?
To join this study, we're looking for healthy adults. This means you should generally be in good health and not have any serious ongoing medical conditions. The study is open to anyone aged 18 years and older.
There isn't an upper age limit mentioned, but you would still need to meet the general health requirements. Both men and women are welcome to take part in this research.
Before you can join, the study team will carry out some checks to make sure it's safe and appropriate for you. They will ask about your health history and perform some simple tests.
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 generally healthy?
- Are you 18 years old or older?
- Are you able to go without food for a set time?
- Are you comfortable having regular blood samples taken?
What does participation involve?
If you decide to take part, you'll be asked to visit the study clinic on a few occasions. The study is designed in two parts, or 'periods'. In each period, you'll receive one dose of a study tablet – either the new Linagliptin or the existing Trajenta®.
Before taking the tablet in each period, you'll need to fast, which means not eating for a certain number of hours. After taking the tablet, the study team will take blood samples regularly over several hours. This helps them measure how the medicine is absorbed and leaves your body. You'll likely stay at the clinic for a full day or overnight during each period. There will be a 'washout' period between the two doses, meaning a period where you don't take any study medication, to make sure the first dose has completely left your system before you take the second.
Overall, the full study duration for you would involve these two dosing periods and any follow-up appointments, which will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedCzechia
Common questions
What is bioequivalence?
Bioequivalence means that a new medicine works in the same way as an existing one, delivering the drug into your body at the same speed and amount.
Why use healthy volunteers?
Using healthy volunteers helps researchers understand how the body processes the medication without other health conditions making the results complicated.
Do I need to fast?
Yes, you will be asked not to eat for a certain period before taking the tablet. This helps ensure consistent results for everyone.
Will I get both tablets?
Yes, you will receive one dose of the new Linagliptin and one dose of Trajenta® at different times over the course of the study.
What happens after I take the tablet?
After taking the tablet, blood samples will be collected over several hours to see how the medicine moves through your body.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.