Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Randomized, open-label, single dose, four-period, cross-over drug-drug interaction study comparing reference products Crestor 20 mg film coated tablets, Norvasc 10 mg tablets and Tritace 10 mg tablets administrated concomitantly versus each drug administrated alone in healthy male and female subjects under fasting conditions.

This is a research study for healthy adults aged 18 and older, both men and women. It aims to understand if taking three common medications together – Crestor (for cholesterol), Norvasc (for blood pressure), and Tritace (also for blood pressure) – changes how your body uses them. The study will compare taking these medicines one at a time versus taking all three at once. This helps doctors know if it's safe and effective to give these medicines together in real-world situations. Because it's an early study, it's not looking at specific health conditions, but rather how healthy bodies process these drugs. Participants will take part over four separate periods, with a break in between each one.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

04 Jul 2023

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

What is this study about?

This research study is about how certain medicines interact with each other in your body. The medicines being studied are Crestor (which lowers cholesterol), Norvasc (which helps with high blood pressure), and Tritace (also for high blood pressure). Doctors sometimes need to prescribe more than one medicine for people to take at the same time.

The main goal of this study is to find out if taking these three medicines together changes how your body handles each one, compared to taking them one at a time. This is really important because drug interactions can sometimes affect how well a medicine works or if it causes side effects. By studying this, researchers can get a better idea of how safe and effective it is to use these medicines in combination.

This kind of study is called a "Phase I" study. This means it's an early-stage study, usually done in healthy volunteers. It helps gather basic information about how drugs work in the body before they are tested in larger groups of people with specific health conditions. For this particular study, participants will take part in four different periods, trying different combinations of the medicines or just one at a time, each separated by a break.

Key takeaways

This study evaluates how three common drugs interact when taken together.
It's an early-stage study in healthy adult volunteers (male and female, 18+).
It compares taking medicines alone versus taking them as a combination.
Participants will have multiple visits, taking medicine on an empty stomach.
The goal is to gather information about drug safety and effectiveness when combined.
Your contribution helps improve future patient care and prescribing practices.

Who may be eligible?

This study is looking for healthy adult volunteers. If you are 18 years old or older, you might be able to take part. This study welcomes both men and women.

Because this study is about how medicines behave in the body generally, it is specifically designed for people who are otherwise healthy. This means that if you have any existing health conditions that require medication or ongoing treatment, this study might not be suitable for you.

The research team will carry out a thorough health check to make sure it's safe for you to participate and that you meet all the necessary requirements for the study.

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 and do not have any ongoing medical conditions?
Are you willing to avoid certain foods or drinks before taking the medicine?
Are you able to visit the study clinic multiple times over several weeks?
Are you comfortable with having regular blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for several weeks, with four separate periods where you visit the study clinic. During each of these four periods, you will receive one of the study treatments – either one of the medicines alone (Crestor, Norvasc, or Tritace) or all three medicines together. These will be given as a single dose tablet, early in the morning before you've eaten anything (this is called "fasting conditions").

After you take the medicine, you will stay at the clinic for a certain amount of time so that the study team can take blood samples regularly. These samples help them understand how your body absorbs, processes, and gets rid of the medicine. There will be a "washout period" – a break – between each of the four treatment periods to make sure the medicines from the previous period have left your system before you start the next one. The total duration of your involvement, including all visits and breaks, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that can help doctors safely prescribe these common medications to other patients in the future. As with any medication, there's always a risk of side effects, even in healthy individuals. The study team will closely monitor you for any reactions and will explain all known potential side effects of the medicines used. Remember, joining a study is always your choice, and you have the right to withdraw at any time without giving a reason, and it won't affect any 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 the main purpose of this study?

The main purpose is to see how three common medicines (Crestor, Norvasc, and Tritace) interact when taken together, compared to taking them one by one, in healthy adults.

Who can take part in this study?

Healthy adult men and women, aged 18 and over, are eligible to participate.

Will I have to stay overnight?

The study involves periods where you will stay at the clinic for several hours after taking the medicine for monitoring and blood tests. Overnight stays may be required for some parts of the study, but this will be fully explained.

What kind of medication will I be taking?

You will be taking single doses of Crestor, Norvasc, and Tritace, either alone or in combination, as these are commonly prescribed medicines.

What does a 'fasting condition' mean?

It means you won't be allowed to eat anything for a certain period before taking the study medication, usually overnight, to ensure consistent results.