Bioequivalence of Mirabegron 50 mg Prolonged-Release Tablets in Healthy Participants Under Fed Conditions.
This clinical research study tests a 50 mg prolonged-release tablet of mirabegron in healthy volunteers. Mirabegron is a medicine usually prescribed to help manage symptoms of an overactive bladder, such as sudden and frequent urges to pee. The main goal of this bioequivalence study is to compare a new version of the medicine with the original, approved version. This ensures that both release the drug into the body at the same speed and in the same amount. In this trial, volunteers will take the tablet after eating a meal to see how food affects its absorption. Because this is an early-stage test of how the tablet behaves, it only involves adults who do not have any ongoing health problems. The results will help confirm whether the new tablet is safe, reliable, and ready for wider use.
At a glance
What is this study about?
Mirabegron is a medicine commonly prescribed to treat an overactive bladder. It works by relaxing the bladder muscles, which helps reduce sudden, urgent trips to the toilet. This trial tests a 50 mg 'prolonged-release' tablet. Prolonged-release means the tablet is designed to break down slowly inside the digestive system, releasing the medicine gradually throughout the day rather than all at once.
When a successful medicine has been available for some time, other pharmaceutical companies often develop their own versions, known as generic medicines. Generic medicines are designed to work in the exact same way as the original, but they often cost the NHS much less to prescribe. To be approved by health regulators, a new generic version must pass a bioequivalence test. This test proves that the new tablet delivers the same amount of active medicine into the blood, and at the same speed, as the original version.
This study also specifically looks at the medicine under 'fed conditions'. This means volunteers take the tablet shortly after eating a standard meal. Food can change how quickly or slowly a tablet dissolves and gets absorbed into the bloodstream. Checking the tablet after a meal ensures it works reliably, no matter what a patient has eaten.
Because the study is designed to measure how the human body processes the medicine—rather than testing if it treats a disease—researchers need healthy volunteers. Testing healthy adults gives clear, clean results without other medical conditions or treatments confusing the data.
Key takeaways
- Tests a new 50 mg prolonged-release mirabegron tablet in healthy adults aged 18 and older.
- Aims to prove the tablet works in the exact same way as the standard, approved version.
- Participants take the medicine after a set meal to see how food affects absorption.
- Requires blood samples and health monitoring at a clinical research facility.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to healthy men and women aged 18 and older. To join, you should generally be in good health and free from any long-term physical or mental health conditions.
You will likely not be able to take part if you have a history of heart conditions, high blood pressure, or liver and kidney issues. People taking regular prescription medicines are usually excluded, as other drugs can change how mirabegron moves through the body. Using recreational drugs or having a history of alcohol misuse may also make you ineligible.
For safety reasons, women who are pregnant, planning a pregnancy, or breastfeeding cannot take part. Before anyone is accepted into the trial, the clinical team will carry out standard health checks, such as blood tests and heart tracings, to ensure it is safe for them to join.
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 aged 18 or older?
- Are you in generally good health with no ongoing medical conditions?
- Are you free from regular prescription medications?
- Are you comfortable having routine blood tests taken?
- If applicable, are you sure you are not pregnant or breastfeeding?
What does participation involve?
Taking part begins with a screening visit where doctors check your medical history, take blood and urine samples, and check your heart with an electrocardiogram (ECG). If you are suitable, you will be invited to a clinical research unit. There, you will eat a set meal and swallow the study tablet with a glass of water. You will stay at the clinic for a set period so the medical team can monitor your health and take blood samples at regular intervals. These blood tests show how much mirabegron enters your bloodstream and how long it stays there. The study concludes with a final follow-up check to make sure you are feeling well. The entire process, from your first screening to your final check-up, usually takes several weeks.
Potential risks and benefits
Locations (1)
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Common questions
Why does the study need healthy people instead of people with bladder problems?
Healthy volunteers allow scientists to measure how the medicine is absorbed without other medical conditions or medicines confusing the results.
What does 'fed conditions' mean?
It means you will eat a specific meal provided by the clinic before taking the tablet, so doctors can see how food affects the medicine.
Is a generic tablet as safe as the branded one?
Yes. Bioequivalence trials are designed specifically to prove that the generic version is just as safe and works just as well as the original.
Will taking part hurt?
The main physical discomfort comes from having blood samples taken using a small needle, which can cause minor stinging or bruising.
Can I leave the study early if I change my mind?
Yes, you can choose to withdraw from the trial at any point, and you do not need to give a reason.
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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