Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A single-dose, randomized, two-period, two-sequence, crossover comparative bioavailability study on formulations containing ramipril, amlodipine and indapamide in combination product versus Triatec® 10 mg capsules (Sanofi - Produtos Farmacêuticos, Lda., Portugal), containing ramipril, Norvasc® 10 mg, tablets (Upjohn EESV, the Netherlands), containing amlodipine and Natrilix® 2.5 mg film-coated tablets (Les Laboratoires Servier, France), containing indapamide co-administered together as reference in healthy male and female volunteers under fasting conditions.

This is a study for healthy adult men and women, aiming to see if a new combined medicine for high blood pressure works in the body similarly to taking the same medicines separately. This new medicine aims to treat high blood pressure, also known as hypertension. Researchers want to make sure that combining ramipril, amlodipine, and indapamide into one tablet means they are still absorbed by your body in the same way as when you take them as separate tablets. This is important to ensure the new combination medicine will be just as effective and safe as the existing individual medications.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Zaklady Farmaceutyczne Polpharma S.A.

Enrolment target

Start

30 Jul 2024

hypertension

What is this study about?

This study is a special type of research designed to compare how a new combination medicine for high blood pressure is handled by your body, compared to taking the individual medicines separately. The new medicine contains three active ingredients: ramipril, amlodipine, and indapamide.

Currently, people with high blood pressure who need these three medicines would take them as three separate tablets. This study wants to find out if putting all three into one tablet means your body absorbs and uses them in the same way. This is very important because it ensures the new combination tablet will deliver the right amount of medicine to be just as effective and safe as taking the separate tablets.

This kind of study is often done early on in the development of new medicines in healthy volunteers. It helps confirm that the new combined tablet is processed by your body exactly as expected, which is a key step before it can be considered for wider use.

Key takeaways

This study is for healthy men and women aged 18 and over.
It compares a new all-in-one blood pressure pill with taking three separate pills.
The main aim is to check if the new pill is absorbed in the body in the same way.
Participation involves clinic visits, blood tests, and taking study medicines.
You will be given both the new combined pill and the separate pills at different times.
Your safety and well-being are a top priority, and you can withdraw at any time.

Who may be eligible?

This study is looking for healthy adult volunteers, both men and women, who are at least 18 years old. There is no upper age limit, as long as you are generally healthy.

The main goal is to find people who are in good health overall and don't have any major medical conditions that might affect how the medicine works in their body. You will be carefully checked by the study doctors to make sure it's safe for you to take part.

It's important that you understand the study requirements and are willing to follow them, including taking the study medicines and attending all appointments.

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 18 years old or older?
Are you generally in good health?
Are you able to attend all clinic visits as required?
Are you comfortable with blood tests and physical exams?
Are you willing to avoid certain foods or activities if asked (e.g., fasting)?
Are you able to commit to the study schedule?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will likely have several visits to the study clinic. You will be given either the new combination medicine or the individual medicines on separate occasions. This is a 'crossover' study, meaning you will receive both types of treatment at different times, with a washout period in between where you don't take any study medicine.

During your visits, typical procedures will involve blood tests to measure how the medicines are absorbed and processed by your body. You might also have physical examinations, blood pressure checks, and heart monitoring. You'll need to follow specific instructions, such as fasting (not eating) before certain visits. The total duration of your participation will include these visits and follow-up periods, and you will be informed of the exact schedule.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit could be contributing to medical knowledge that might help people with high blood pressure in the future by making their treatment simpler. As you are a healthy volunteer, you won't directly benefit from the medicine for high blood pressure. Potential risks might include side effects from the study medication, although these medicines are well-known and generally safe. There might also be discomfort from blood tests or other procedures. You will be fully informed of all potential risks before you decide to join, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your future medical care.

Locations (1)

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

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Unverified
Czechia

Common questions

What is high blood pressure?

High blood pressure, or hypertension, means the force of your blood pushing against your artery walls is consistently too high. It can lead to serious health problems if not treated.

What does a 'combination product' mean?

A combination product means a single tablet that contains more than one active medicine inside it. In this case, it's one tablet with three different medicines for high blood pressure.

What is a 'bioequivalence' study?

A bioequivalence study checks if two different versions of a medicine deliver the active ingredients to your body in the same way and at the same rate. Here, it compares a new combined tablet with taking the medicines separately.

Will I know if I'm getting the new combination or the separate medicines?

Because this is a 'crossover' study, you will get both the new combination and the separate medicines at different times during the study to allow for a fair comparison.

Will I get paid for taking part?

Many clinical studies offer some level of reimbursement for your time, travel, and inconvenience. This will be explained to you in detail before you agree to participate.