Multiple-Dose Bioequivalence of Mirabegron 50 mg Prolonged-Release Tablets in Healthy Participants Under Fasting Conditions.
This early-stage study is testing a medicine called mirabegron, which is commonly used to treat overactive bladder symptoms. Researchers are looking at a 50 mg slow-release tablet to see if it behaves in the exact same way as the original, approved brand. This kind of test is called a bioequivalence study. Because the main aim is to measure how the human body absorbs and clears the tablet, researchers are looking for healthy volunteers rather than people with bladder issues. Volunteers will take repeated doses of the tablets on an empty stomach. Medical staff will collect blood samples at set times to measure the amount of medicine in the blood. Studies like this are vital because they help make sure that alternative, often more affordable versions of standard medicines are just as safe and effective before they are given to patients in the NHS.
At a glance
What is this study about?
Mirabegron is an established medicine that helps relax the bladder muscles, easing problems such as sudden urges to urinate. When a medicine has been used successfully for several years, other manufacturers can produce their own versions. Before any new version can be approved for use, researchers must prove that it delivers the medicine into the body in the exact same way as the original. This trial is designed to test that comparison.
In this study, the tablet is 'prolonged-release', meaning the active drug is slowly absorbed into the body over several hours rather than all at once. Volunteers will take multiple doses while fasting, which means not eating for a set time before taking the tablet. Testing on an empty stomach helps researchers see how the tablet breaks down on its own, without food getting in the way.
Healthy adults take part in this research because underlying health conditions or other medicines could alter the test results. By checking blood samples from healthy volunteers, scientists can get clear, accurate data about how the tablet dissolves, enters the blood, and leaves the body.
Taking part in this type of pharmacology study helps support wider healthcare. Demonstrating that alternative medicines work identically to existing ones helps make treatments more widely available and can lower costs for public health services such as the NHS.
Key takeaways
- Tests whether a new slow-release mirabegron tablet works identically to the established brand.
- Looking for healthy adult volunteers aged 18 and older.
- Involves taking tablets on an empty stomach and having regular blood samples taken.
- Offers no personal medical treatment, but volunteers help confirm safe and affordable medicines.
- Participation is completely voluntary and you can leave the study at any time.
Who may be eligible?
This study is open to healthy men and women aged 18 and over. Because the trial is designed purely to test how a healthy body handles the tablet, you do not need to have any bladder conditions or other illnesses to join.
You may not be able to take part if you take regular prescription medicines, have high blood pressure, or have a history of heart, liver, or kidney problems. Women who are pregnant, planning to become pregnant, or breastfeeding will also be excluded to protect their safety and their baby's health.
Before taking part, the research team will carry out a thorough health check. This usually involves checking your medical history, taking your blood pressure, performing a heart tracing test (ECG), and testing your blood and urine to confirm that you are in good general health.
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 at least 18 years old.
- I consider myself to be in good overall health.
- I do not have long-term heart, kidney, or liver conditions.
- I am not taking regular prescription medicines.
- I am not pregnant or breastfeeding.
- I am comfortable having regular blood samples taken.
What does participation involve?
Taking part usually involves an initial screening visit to check your general health, followed by a stay or several visits at a specialist clinical research unit. During the study, you will take the mirabegron tablet with water after fasting overnight. Over the course of several days, nurses will take small blood samples at regular time intervals to track the medicine levels. A tiny plastic tube (cannula) is often placed in your arm so you do not need a fresh needle prick each time. Staff will also regularly monitor your pulse, blood pressure, and heart rhythm. Once the dosing and blood tests are complete, you will have a final check-up to ensure you remain well. The study team will explain the exact number of days and clinic visits before you agree to join.
Potential risks and benefits
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Common questions
What does 'bioequivalence' mean?
It means proving that two different versions of the same medicine release the exact same amount of active ingredient into your blood at the same speed.
Do I need to have a bladder problem to join?
No. This study needs healthy volunteers without bladder issues so that researchers can measure the medicine without other health conditions affecting the results.
Why do I have to take the medicine on an empty stomach?
Fasting ensures that food does not change how quickly or slowly the tablet dissolves, giving the researchers clear and consistent test results.
Will I be compensated for my time?
Phase 1 trials with healthy volunteers usually provide payment to cover your time and travelling expenses. The study team can give you details on this.
Can I leave the study if I change my mind?
Yes. Joining a clinical trial is always voluntary, and you can stop taking part at any point without giving 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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