Bioequivalence clinical trial of two formulations of empagliflozin/metformin
This clinical trial is comparing two versions of a combined medication containing empagliflozin and metformin, which are medicines commonly used to manage type 2 diabetes. The goal is to prove that a new tablet formulation behaves in the exact same way as an already approved version inside the human body. This type of research is called a bioequivalence study. Because this is an early-stage pharmacology study, doctors are inviting healthy adult volunteers to take part rather than people living with diabetes. By studying healthy individuals, researchers can accurately track how the body absorbs, breaks down, and clears the medicine without other health conditions clouding the findings. Participants will attend a clinic for health checks, take the trial tablets, and provide regular blood samples. The findings will help make sure that patients in the future have access to safe, reliable, and potentially more affordable treatment options.
At a glance
What is this study about?
Empagliflozin and metformin are two widely prescribed medicines that help people with type 2 diabetes manage their blood sugar levels. Often, these two drugs are combined into a single, convenient tablet so people do not need to take multiple pills each day. This trial is looking at a new version of this combination tablet to make sure it works identically to the established version.
When pharmaceutical scientists create a new version or generic form of a medicine, they must carry out a 'bioequivalence' study. This simply means proving that the new pill releases the active ingredients into the bloodstream at the same rate and in the same amount as the original pill. If the levels in the blood match, doctors can be confident that the new tablet will be just as safe and effective for patients.
To test this fairly, researchers recruit healthy volunteers. In people without diabetes, the body processes the medication in a predictable way. This allows scientists to measure exact blood levels over time without the results being altered by fluctuating blood sugar levels, kidney changes, or other medications that someone with diabetes might be taking.
Overall, studies like this are an essential part of medicine development. They help widen access to vital treatments, support the NHS by providing more cost-effective options, and maintain high standards of safety and quality for everyone who relies on daily medication.
Key takeaways
- The trial compares a new combination tablet of empagliflozin and metformin against an existing one.
- The main goal is to prove both tablets deliver the same amount of medicine into the body.
- The study is designed for healthy adult volunteers aged 18 and over.
- Participants will stay at a clinic for short periods and give regular blood samples.
- Joining is entirely voluntary and you can leave the study at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who are in good general health. Both men and women can apply. Because this trial checks how a standard body processes the medicine, volunteers must not have any major ongoing medical conditions.
You are unlikely to be eligible if you have type 2 diabetes, kidney disease, liver problems, or serious heart conditions. People taking regular prescription medicines are usually excluded, as these could interfere with the study tablets. Women who are pregnant, planning to become pregnant, or breastfeeding will also not be able to join for safety reasons.
Before taking part, a clinic doctor will carry out a thorough health check, which includes reviewing your medical history, taking blood and urine samples, and checking your heart rhythm to make sure it is safe for you to take part.
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.
- I am aged 18 or older.
- I consider myself to be in good general health.
- I do not have diabetes, kidney disease, or liver problems.
- I am not taking regular prescription medications.
- I am not pregnant or breastfeeding.
- I am able to attend clinic visits and stay overnight if required.
What does participation involve?
Taking part usually involves an initial screening visit followed by one or more short stays at a specialist clinical research unit. During your stay, you will receive a single dose of the study tablet with water. Medical staff will take regular blood samples over a set number of hours and days to track how much medicine enters your blood and how quickly your body clears it. You will also have standard checks like blood pressure, heart rate, and temperature taken throughout your stay. Most bioequivalence studies use a 'crossover' design, meaning after a rest period of a week or two, you return to test the second tablet formulation. The entire study typically lasts between two to six weeks from your first check-up to your final follow-up visit.
Potential risks and benefits
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Common questions
What does 'bioequivalence' mean?
It means two different versions of the same medicine deliver the exact same amount of active ingredient into your blood at the same speed, ensuring they work equally well.
Why test a diabetes drug on healthy people?
Healthy volunteers give a clear, standard baseline. This allows researchers to measure how the drug moves through the body without the results being confused by underlying illness.
Will taking this medicine give me low blood sugar?
Metformin and empagliflozin carry a very low risk of causing low blood sugar (hypoglycaemia) on their own, but study doctors monitor you closely just in case.
Will I be paid for taking part?
Phase I trials with healthy volunteers usually provide payment to compensate you for your time, travel, and any overnight stays at the clinic.
Can I leave the study early if I feel uncomfortable?
Yes. Taking part is completely voluntary, and you have the right to withdraw at any time without needing to give an explanation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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