Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomized, open-label, single dose, two-period, cross-over bioequivalence study comparing test formulation Rosuvastatin/Amlodipine/Ramipril capsule, hard 10mg/5mg/5mg versus reference products Crestor 10 mg film coated tablets, Norvasc 5 mg tablets, Tritace 5 mg tablets in healthy male and female subjects under fasting conditions. Sponsor’s Study Number: ROS-AML-RAM-BIO-02-23

This study is looking at a new combination pill that contains three medicines often used together to help with heart conditions: rosuvastatin, amlodipine, and ramipril. Instead of taking three separate tablets, this new pill aims to combine them into one. The purpose of this study is to compare how the new combined pill works in the body versus taking the three medicines separately. Researchers will give healthy volunteers either the new combination pill or the three individual medicines on different occasions. They will then take blood samples to measure how much of each medicine gets into the body and how quickly. This helps ensure the new combination pill acts in the same way as the separate medicines, making sure it’s just as effective and safe for future patients who might need these medications.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

16 May 2023

Not applicable (submitted trial is a bioequivalence study in healthy subject).

What is this study about?

This research study is about checking a new combined medicine. Currently, many people who need these medicines take them as three separate tablets. This new study is looking at a single pill that combines all three: rosuvastatin, amlodipine, and ramipril. These medicines are commonly used to help manage heart health, for example, by lowering cholesterol (rosuvastatin), controlling blood pressure (amlodipine), and protecting the heart and blood vessels (ramipril).

The main goal of this study, called a bioequivalence study, is to see if the new combination pill works in exactly the same way as taking the three medicines separately. This means scientists want to make sure that the new pill delivers the same amount of each medicine into the body, achieves similar levels in the blood, and works at the same speed as the individual tablets. This is really important because if a new combined medicine acts differently, it might not be as effective or could even have unexpected side effects.

To find this out, healthy volunteers will take both the combined pill and the separate pills at different times. Researchers will then closely monitor how the medicines are absorbed, how much gets into the bloodstream, and how long they stay there. By doing this comparison, they can confirm that the new single pill provides the same treatment benefits as the existing separate medications, potentially making it simpler and easier for patients to take their medicines in the future.

Key takeaways

This study tests a new 'three-in-one' pill for heart health.
It compares the new pill to taking three separate medicines.
The goal is to ensure the new combined pill works just as well.
Participants will be healthy adult men and women.
Blood samples will be taken to measure medicine levels.
This research aims to simplify medicine taking for patients.

Who may be eligible?

This study is looking for healthy adult volunteers. Both men and women are welcome to take part. You must be at least 18 years old to be considered.

The study is specifically designed for healthy individuals. This means you should not have any ongoing medical conditions that might affect how your body handles the medicines being tested. The researchers will perform health checks to make sure you are suitable.

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 healthy with no serious existing medical conditions?
Are you comfortable with attending clinic visits?
Are you able to provide regular blood samples?
Are you able to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will visit the clinic several times. You will be given either the new combination pill or the separate individual medicines on different occasions. You won't know which one you're taking at any given time, and sometimes the researchers won't know either to keep the results fair. During your visits, you will have regular blood samples taken, especially after you've taken the medicine. These blood tests help the researchers measure how the medicines are working in your body.

This study is structured in two periods. In one period, you'll take one type of medication (either the combined pill or the separate ones), and in the other period, you'll take the other type. There will be a 'washout' period in between, where you don't take any study medication, to make sure the first dose has left your system before you take the second type. The total duration of your involvement, including all visits and washout periods, will be explained fully by the study team.

Potential risks and benefits

Participating in this study might offer a small benefit by contributing to medical science and potentially making it easier for future patients to take their medicines. As you are taking medicines, there's always a risk of side effects, although these medicines are well-known and generally safe at these doses. The study is conducted under strict medical supervision to manage any potential risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 a 'combination pill'?

It's one tablet that contains several different medicines, making it easier to take multiple treatments at once.

Why is this study only for healthy people?

Studies like this need healthy people to clearly see how the medicine acts in the body without other health conditions making the results unclear.

What are rosuvastatin, amlodipine, and ramipril for?

These are common medicines used to help manage heart conditions, for example, by lowering cholesterol and blood pressure.

What does 'bioequivalence' mean?

It means the study checks if two different versions of a medicine (like a new combination pill vs. separate pills) work in the body in exactly the same way.

Will I know which medicine I'm taking?

No, this type of study is often 'blinded', meaning you won't know if you're taking the combination pill or the separate ones at any given time, to ensure fair results.