Bioequivalence clinical trial of two formulations of dapagliflozin/metformin
This Phase 1 study looks at two formulations of a combined tablet containing dapagliflozin and metformin. These medicines are widely prescribed to help manage blood sugar levels in people with type 2 diabetes. The main aim of a 'bioequivalence' study is to check whether a new version of a medicine behaves in the exact same way inside the body as an established version. Researchers measure how quickly the tablets dissolve and enter the bloodstream, and how long they stay there. Because this trial focuses purely on how the body processes the medication, it is open to healthy adult volunteers aged 18 and older. Participants will take the tablets under close medical observation and provide blood samples over set periods. Taking part helps ensure that alternative or generic versions of common treatments are just as safe and reliable as the originals.
At a glance
What is this study about?
Dapagliflozin and metformin are two well-known medications frequently used together to treat type 2 diabetes. Metformin helps the body respond better to insulin and lowers glucose production in the liver, while dapagliflozin helps the kidneys remove extra sugar through the urine. Combining them into a single tablet makes daily treatment simpler for patients.
When a manufacturer develops a new version of an approved medicine, such as a generic tablet, regulators require proof that it behaves identically to the original. This is called a bioequivalence study. Rather than testing whether the medicine treats a disease, the study measures how the body absorbs, breaks down, and clears both formulations. If both versions produce matching blood levels, they are considered bioequivalent.
These studies are usually carried out in healthy volunteers. Testing the medicine in people without diabetes provides a clear picture of how the tablet acts on its own, without being affected by fluctuating blood sugar levels, other health conditions, or additional medications. This keeps the data accurate and reliable.
Taking part in this research supports the development of affordable, high-quality treatment options. Ensuring that different brands and formulations perform consistently gives healthcare providers and patients confidence that the medicine they receive will work as expected.
Key takeaways
- The trial compares two tablet formulations of dapagliflozin and metformin to check they perform identically.
- It is open to healthy adult volunteers aged 18 and older, not people with diabetes.
- Participants take the study tablets and provide regular blood samples to measure medicine levels.
- Volunteers are closely looked after in a clinical unit with round-the-clock medical supervision.
- Taking part is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to healthy adults aged 18 and older of any sex. Because the study measures how the body processes the medicine without interference from other conditions, volunteers must generally be in good overall health.
People with chronic health conditions, especially kidney problems, heart conditions, liver disease, or a history of diabetes, are usually not able to join. These conditions could alter how the body clears the medication or increase the risk of side effects.
You will also likely be excluded if you take regular prescription medicines, smoke heavily, use recreational drugs, or are pregnant or breastfeeding. A full health screening, including blood and urine tests, is carried out before anyone can enrol.
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 am in good general health with no major medical conditions.
- I do not have diabetes, kidney disease, or liver problems.
- I am not currently taking regular prescription medicines.
- I am not pregnant, planning to become pregnant, or breastfeeding.
What does participation involve?
Taking part in this study typically involves an initial screening visit followed by one or more study periods. During screening, the clinical team will check your medical history, measure your blood pressure, perform an electrocardiogram (ECG) to check your heart rhythm, and take blood and urine samples to confirm you are healthy.
During the trial periods, you will receive a single dose of one formulation and, after a rest period called a 'washout', a single dose of the other formulation. You may need to stay overnight in a specialised clinical research unit so doctors and nurses can monitor you closely. Staff will take small, regular blood samples over several hours or days to track medicine levels in your blood.
After all testing is complete, you will attend a short follow-up visit to make sure you are feeling well. The entire study usually takes anywhere from a few weeks to a couple of months from your first screening to your final check-up.
Potential risks and benefits
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Common questions
What does 'bioequivalence' mean?
It means two different versions of the same medicine release the active ingredients into your bloodstream at the same speed and in the same amount, making them work the same way.
Do I need to have diabetes to take part?
No. In fact, this trial is specifically designed for healthy volunteers who do not have diabetes or other major health conditions.
Are travel expenses or time compensated?
Phase 1 trials involving healthy volunteers often provide compensation for your time, travel, and any inconvenience, in line with UK ethical guidelines.
Will taking these tablets make my blood sugar dangerously low?
Metformin and dapagliflozin have a low risk of causing severe low blood sugar on their own, but study doctors will monitor your glucose levels closely while you take part.
Can I leave the study if I change my mind?
Yes. Taking part is entirely voluntary, and you are free to stop and leave the study at any point without penalty.
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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