Multiple-Dose Study in Healthy Participants Under Fasting Conditions to Evaluate the Bioequivalence of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide SR 1.5 mg and to Compare the Bioavailability of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide IR 2.5 mg.
Indapamide is a widely used medicine that helps lower high blood pressure. However, some people find standard tablets hard to swallow. To make taking medication easier, scientists have developed a new 'mini-tablet' version. This early-stage study is testing whether this new mini-tablet releases the medicine into the body in the same way as existing tablets. It will compare the mini-tablet against two current forms: a standard slow-release tablet and a standard fast-release tablet. The study involves healthy adult volunteers who will take the medicine after fasting (not eating for a set time). Doctors will take regular blood samples to track how much medicine enters the bloodstream and how fast it gets there. The results will help confirm if the new, smaller design is just as reliable as the medicines doctors currently prescribe.
At a glance
What is this study about?
Indapamide is a well-known medicine commonly prescribed across the UK to help manage high blood pressure. It works gently on the kidneys to remove extra salt and water from the body, which relaxes blood vessels and lowers blood pressure. While the medicine works well, some people struggle to swallow standard tablets every day. To address this, researchers have designed a smaller 'mini-tablet' that aims to be much easier to take.
Before a new tablet size or shape can be prescribed by doctors, researchers must prove that it behaves in the human body exactly like the original medicine. This type of research is called a 'bioequivalence' study. Scientists want to confirm that the smaller tablet dissolves at the correct rate, releases the right amount of medicine, and does not cause unexpected changes in how the body processes it.
In this study, healthy volunteers will take the new mini-tablet as well as standard indapamide tablets on separate occasions, with a break in between. Because the participants are healthy, researchers can clearly observe how the medicine travels through the body without interference from other health conditions. If the mini-tablet performs just as well, it could provide a much more comfortable option for patients who need long-term blood pressure treatment.
Key takeaways
- Tests a new, smaller 'mini-tablet' designed to be easier to swallow.
- Open to healthy adult volunteers aged 18 and older.
- Compares how the body absorbs the new tablet versus standard existing tablets.
- Requires taking the medicine on an empty stomach and having routine blood tests.
- Participation is voluntary, carefully supervised, and can be stopped at any time.
Who may be eligible?
This study is looking for healthy adult volunteers aged 18 and older. Both men and women can apply. Because this trial is designed to test how the body handles the tablet itself rather than treating an illness, participants must not have any serious long-term medical conditions.
You are unlikely to be eligible if you already have high or low blood pressure, kidney problems, liver conditions, or a known allergy to indapamide or similar medicines. People who are pregnant, breastfeeding, or taking regular prescription medicines that could interfere with the study are also unable to take part.
Before joining, the research team will carry out a thorough health check. This includes checking your medical history, taking blood and urine tests, and doing a physical examination to ensure that it is completely safe for you to participate.
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 overall health.
- I do not have high blood pressure, kidney disease, or liver problems.
- I am not currently pregnant or breastfeeding.
- I am willing to fast overnight and attend clinic visits for blood tests.
What does participation involve?
Taking part in this study usually involves staying at a specialist clinical research clinic for short periods, alongside a few outpatient visits. Before the trial begins, you will attend a screening appointment to check your overall health. During the study, you will take doses of the medicine on an empty stomach (after fasting overnight). Over the course of the study, you will try the different tablet forms with resting breaks—known as 'washout periods'—in between to allow the medicine to leave your system completely. The clinic team will take regular, small blood samples to measure the drug levels in your body, and they will regularly monitor your blood pressure and heart rate. A final health check will take place at the end of the trial, with the whole process usually lasting several weeks.
Potential risks and benefits
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Common questions
What is the purpose of this study?
The study checks whether a new, easier-to-swallow mini-tablet of indapamide delivers the medicine into the bloodstream just as well as standard tablets.
Do I need to have high blood pressure to take part?
No. This study requires healthy volunteers who do not have high blood pressure or other chronic conditions.
Why do I have to fast before taking the medicine?
Food can change how quickly a medicine is absorbed. Fasting ensures that all participants absorb the tablet under identical conditions, giving clear and fair results.
Will taking part hurt?
Swallowing the tablets should be painless. You will need regular blood tests, which can cause brief discomfort or slight bruising, but staff are trained to make this as gentle as possible.
Can I leave the study if I change my mind?
Yes. Taking part is entirely voluntary. You can choose to stop and leave the trial at any point, and you do not have to provide 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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