Single-Dose Study in Healthy Participants 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 Under Fasting Conditions, and to Compare the Bioavailability of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg Under Fasting versus Fed Conditions.
Indapamide is a common medicine used to lower high blood pressure. Researchers have created a new, smaller 'mini-tablet' designed to release the medicine slowly throughout the day. This study aims to find out how well the body absorbs this new mini-tablet compared to a standard, immediate-release tablet. The trial is open to healthy volunteers aged 18 and over. Researchers also want to see whether eating a meal before taking the mini-tablet affects how the drug enters the bloodstream, compared to taking it on an empty stomach. Participants will receive single doses of the study medicine and have regular blood samples taken to measure drug levels. Because this is an early-stage study in healthy volunteers, there is no direct medical benefit to participants, but taking part helps improve medicine design for people who have difficulty swallowing pills.
At a glance
What is this study about?
Indapamide is a well-established medicine widely prescribed in the UK to help treat high blood pressure. It works gently on the kidneys to help remove excess salt and water from the body, which helps blood vessels relax. While the medicine is already trusted and effective, scientists are always working on ways to make tablets easier for patients to take. For some people, especially older adults, large pills can be hard to swallow.
In this study, researchers are testing a new 'mini-tablet' of indapamide. This smaller pill is designed as a 'sustained-release' tablet, which means it releases its medicine slowly over time. The study will compare this 1.5 mg mini-tablet to a standard 2.5 mg 'immediate-release' tablet to check if the body absorbs the medicine in a similar, safe way.
The study also looks at the effect of food. Sometimes, having food in your stomach can speed up, slow down, or block the absorption of a medicine. Volunteers will take the mini-tablet both after fasting (having an empty stomach) and after eating a meal, allowing doctors to see if food makes any difference.
By taking part, healthy volunteers help scientists gather important facts about how the medicine moves through the human body. This ensures that when the mini-tablet is prescribed to patients in the future, doctors know exactly how to dose it safely.
Key takeaways
- The trial compares a new, smaller indapamide mini-tablet with a standard tablet.
- Researchers want to see how the body absorbs the medicine and whether food affects it.
- Open to healthy adults aged 18 and over with no major medical conditions.
- Involves taking single doses and having routine blood tests to measure medicine levels.
- Participation is voluntary, closely monitored by doctors, and you can leave at any time.
Who may be eligible?
This study is looking for healthy men and women aged 18 and older. Because this trial is designed to test how the human body naturally processes the medicine, volunteers must not have any major ongoing health conditions.
To take part, you should generally be in good health with normal blood pressure and kidney function. You will likely be asked not to take regular prescription medicines, over-the-counter drugs, or herbal supplements during the study periods, as these could interfere with the results.
You may not be eligible if you are pregnant, breastfeeding, have a history of heart, liver, or kidney problems, or have known allergies to indapamide or similar medicines. The study clinic will carry out routine health checks before you can 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.
- I am aged 18 or older.
- I consider myself to be in good general health.
- I do not have high blood pressure, kidney disease, or heart conditions.
- I am not currently pregnant or breastfeeding.
- I am happy to undergo routine health checks and regular blood tests.
What does participation involve?
Taking part usually involves an initial screening visit followed by short clinic stays or daytime visits. During screening, doctors will check your general health, blood pressure, heart rhythm, and take routine blood and urine samples. For the study itself, you will take single doses of indapamide as tablets. You will test the medication under different conditions, such as after an overnight fast and after eating a set meal. Across the study days, staff will take small, regular blood samples over several hours to measure the level of medicine in your system. You will also be monitored to make sure your blood pressure stays safe. The trial team will confirm the exact number of visits and total duration during your screening.
Potential risks and benefits
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Common questions
What is indapamide used for?
Indapamide is a water tablet (diuretic) commonly prescribed by GPs to help reduce high blood pressure and protect against heart problems and strokes.
Why is this study using healthy volunteers instead of patients?
Healthy volunteers allow researchers to see how a medicine is absorbed and cleared by the body without interference from other illnesses or daily medications.
Will taking this medicine lower my blood pressure too much?
Because indapamide lowers blood pressure, healthy volunteers are given low, single doses and monitored closely by medical staff to ensure blood pressure stays within safe levels.
Are travel expenses covered for taking part?
Phase 1 studies in healthy volunteers typically offer compensation for your time and travel expenses. The study team will explain the exact details before you agree to join.
Can I leave the study if I change my mind?
Yes. Joining a clinical trial is entirely voluntary, and you are free to stop participating at any point without any 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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