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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomized, single dose, cross-over bioavailability study comparing the drug-drug interaction between telmisartan tablets, indapamide tablets, and amlodipine tablets when co-administered versus the administration of each product alone in three arms to healthy volunteers under fasting conditions.

This research study is about understanding how three different medications for high blood pressure interact with each other in the body. These medicines are called telmisartan, indapamide, and amlodipine. We want to see if taking them together changes how much of each medicine gets into your system, compared to taking them separately. Healthy adult volunteers will take each medicine alone and then all three together, on different occasions. This helps scientists learn about how the body uses and processes these drugs, which is important for making sure people with high blood pressure get the most benefit from their treatment. It's a very early stage study, focused on safety and how the drugs are handled by the body.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Cepha s.r.o., PRO.MED.CS Praha a.s.
Enrolment target
96
Start
12 Jun 2024

What is this study about?

Imagine you have high blood pressure, and your doctor prescribes you a medicine to help. Sometimes, people need to take more than one medicine to get their blood pressure under control. This study is designed to carefully look at three specific blood pressure medications: telmisartan, indapamide, and amlodipine. We want to understand what happens when these three medicines are taken together, compared to when each one is taken on its own.

Think of it like baking a cake. If you add flour and eggs separately, they behave a certain way. But if you mix them, they combine and create something new. In a similar way, we need to know if these medicines change how they work or how much of them gets into your body when they're taken at the same time. This is called a 'drug-drug interaction' study.

By having healthy volunteers take these medicines in different combinations, we can measure how the body absorbs, distributes, and removes each drug. This information is really important because it helps doctors safely and effectively prescribe these medicines to people who need them for managing their high blood pressure. It makes sure that patients get the right amount of medication for their condition.

Key takeaways

  • Studies how three blood pressure medicines interact when taken together.
  • Aims to understand how medicines behave in the body.
  • Involves healthy adult volunteers, aged 18 and over.
  • Participation includes multiple visits and blood tests.
  • Helps improve safe and effective treatment for high blood pressure.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part.

Key to this study is that you must be healthy, meaning you don't have any major medical conditions that could affect how the medicines work or put your health at risk. The study will involve a dose of medication, so it's important that your body can handle it well.

Anyone interested will have a medical check-up to make sure they are suitable and safe 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.

  1. Are you 18 years old or older?
  2. Are you generally in good health?
  3. Are you able to fast (not eat) for periods before taking medication?
  4. Are you willing to attend several clinic visits?
  5. Are you comfortable with having blood samples taken occasionally?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic several times. You'll be given a single dose of the study medications on different occasions. This means you might take telmisartan by itself one time, indapamide by itself another time, amlodipine by itself on a third occasion, and then all three together on a fourth visit. These will be spaced out over some time. Each time you take the medicine, we will need to take blood samples over several hours to see how the medication levels change in your body. You'll likely need to fast (not eat) before each dose. The total duration of your participation, including all visits and follow-ups, will be explained fully at the start.

Potential risks and benefits

The main benefit of taking part in this study is that you would be contributing to scientific knowledge that helps improve future treatments for people with high blood pressure. You would also receive a health check-up. As with any medication, there can be potential risks, such as side effects from the medicines, which will be fully explained to you before you agree to participate. You will be monitored closely by medical staff, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Czechia

Common questions

What is high blood pressure?

High blood pressure (hypertension) is when the force of your blood pushing against the walls of your arteries is consistently too high. It can lead to serious health problems like heart disease or stroke if not managed.

What kind of medicines are being studied?

We are studying three common medicines used to treat high blood pressure: telmisartan, indapamide, and amlodipine. They all work in slightly different ways to help lower blood pressure.

Will I get paid for taking part?

Information about payment or compensation for your time and inconvenience will be provided during the consent process, should you be eligible and interested in participating.

How long will I be involved in the study?

The total length of your involvement will be explained to you in detail if you are considered for the study. It typically involves several visits over a period of weeks.

Will I receive any of these medicines for my own high blood pressure?

No, this study involves healthy volunteers and is not for treating your own high blood pressure. The doses are for research purposes only.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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