An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Empagliflozin Tablets 25 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Jardiance (Empagliflozin) 25 mg film-coated tablets, Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany, in healthy adult, human subjects under fasting condition.
This research is looking at two forms of a medicine called Empagliflozin, which is used to treat diabetes. One is the original medicine (Jardiance), and the other is a new version made by a different company. The main goal is to check if these two versions are absorbed by the body in the same way and at the same speed. This is important to ensure the new version is just as effective and safe as the original. Healthy adult volunteers will take a single dose of each medicine on separate occasions, and scientists will take blood samples to compare how the medicines act in their bodies. This type of study is called a ‘bioequivalence’ study and is a standard step for new medicines.
At a glance
What is this study about?
This study is about a medicine called empagliflozin, which is prescribed for people with type 2 diabetes. Currently, a branded version called Jardiance is available. This study is testing a new, unbranded version of empagliflozin, made by a different pharmaceutical company, to see if it works in exactly the same way as Jardiance.
When a new version of an existing medicine is developed, it needs to be proven that it’s just as effective and safe as the original. This is done by comparing how the body absorbs and uses both medicines. This type of study is called a bioequivalence study. Essentially, researchers want to make sure the new version gets into your bloodstream at the same rate and in the same amount as the original, so it can have the same effect.
Healthy adult volunteers will take part in this research. They will be given a single dose of each medicine at different times, and their blood will be tested to measure how much of the medicine is present and for how long. This careful comparison helps regulatory bodies, like the MHRA in the UK, decide if the new version can be approved for use, ensuring patients receive consistent and reliable treatment.
Key takeaways
- This study compares a new diabetes medicine (Empagliflozin) with an existing one.
- The goal is to ensure the new version works just as well and safely.
- Healthy adult volunteers, aged 18 and over, are needed.
- You will take single doses of each medicine under medical supervision.
- Blood samples will be taken to see how the medicines affect your body.
- Your participation helps to bring new, safe medicines to patients in the future.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should be generally well and not have any serious health conditions that might affect how your body handles the medicine.
People aged 18 and over are welcome to participate. There’s no upper age limit, as long as you're in good health otherwise. The study is open to both men and women.
To be eligible, you must be able to follow the study instructions carefully, including coming to all scheduled appointments and following certain dietary guidelines, particularly regarding fasting before taking the medicine.
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, without ongoing serious medical conditions?
- Are you able to fast before taking medication?
- Are you available for multiple clinic visits?
- Are you able to follow detailed study instructions?
What does participation involve?
If you decide to take part, you will be in the study for a short period, as it only involves single doses of medication. You'll switch between the two different versions of the medicine, trying one first and then the other after a break. Before you take each medicine, you will need to fast, meaning you won’t be able to eat or drink anything (except water) for a certain number of hours.
During your time in the study, you'll visit the clinic for several appointments. At these visits, doctors and nurses will take blood samples to measure how the medicine is behaving in your body. There will also be other health checks to make sure you remain well throughout the study. The exact number of visits and the total time frame will be explained in detail before you agree to take part.
Potential risks and benefits
Locations (1)
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Common questions
What is 'Empagliflozin'?
Empagliflozin is a medicine primarily used to help manage type 2 diabetes.
What does 'bioequivalence' mean?
It means we are checking if two different versions of the same medicine work in the same way inside your body.
Will I receive the diabetes medicine?
Yes, you will receive single doses of both the original and the new version of the medicine during the study.
Do I have to have diabetes to join?
No, this specific study is looking for healthy adult volunteers, not people with diabetes.
Will I be paid for taking part?
Payment for participation in healthy volunteer studies is common, and specific details would be given to you by the research 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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