Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing ticagrelor 90 mg hard capsules (PG402 [Celon Pharma]) vs ticagrelor 90 mg film-coated tablets (Brilique [AstraZeneca AB]) under fasting conditions in healthy volunteers

This study is looking at a new version of a medicine called ticagrelor, which comes as a hard capsule. We are comparing it to the ticagrelor tablet (Brilique®) that is already available. The main goal is to check if the new capsule works in the body in the same way as the current tablet when taken on an empty stomach by healthy adult volunteers. Ticagrelor is an important medicine used to help prevent serious heart issues, such as heart attacks, in people who have already had them or are at high risk. This type of study, called a bioequivalence study, is a key step in medicines development to ensure that new versions of a drug are just as effective and safe as the original.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Celon Pharma S.A.

Enrolment target

Start

16 Oct 2023

Prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event

What is this study about?

This study is about a medicine called ticagrelor. You might know it by its brand name, Brilique®. Ticagrelor is really important for people who have had a heart attack or are at a high risk of having one. It works by stopping your blood from clotting too easily, which can prevent future heart problems.

Here, we're testing a new way to take ticagrelor: as a hard capsule. Currently, it's given as a film-coated tablet. Our main goal is to make sure this new capsule works in exactly the same way as the tablet that's already used. We call this a 'bioequivalence' study. It means we're checking if your body absorbs and uses the new capsule version of the medicine in the same amount and at the same speed as the tablet.

This is a crucial step in bringing new medicines, or new forms of existing medicines, to patients. It helps doctors and patients be confident that a new version of treatment will be just as effective as what they're using now. By studying healthy volunteers, we can understand how the medicine behaves without other illnesses affecting the results.

Key takeaways

Tests a new ticagrelor capsule against the current tablet.
Aims to prove the capsule works the same as the tablet.
Involves healthy adult volunteers, not patients.
Requires taking medication on an empty stomach.
Helps advance new treatment options for heart conditions.
Your health will be monitored closely throughout the study.

Who may be eligible?

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

It's important that you don't have any major ongoing health problems. The study is designed for healthy people to understand how the medicine works in a typical body, not for patients already being treated for specific conditions. You'll have medical checks to make sure you're healthy enough to participate.

There will be other specific rules you'll need to meet, for example, about other medicines you might be taking or certain lifestyle choices. The study team will discuss all of these with you in detail to see if this study is a good fit.

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?
Do you not have any major ongoing medical conditions?
Are you able to follow specific study instructions, like fasting?
Are you willing to have blood samples taken regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in a 'crossover' study. This means you'll receive both the new ticagrelor capsule and the standard ticagrelor tablet at different times, with a break in between. You'll take each medicine just once. You'll be asked to fast (not eat) before taking the medicine each time.

Your participation will involve several visits to the study clinic. On dosing days, you'll receive the medicine and then have several blood samples taken over a set period to see how your body handles the drug. You'll also have health checks, like measuring your blood pressure and heart rate. There will be a follow-up visit after your last dose. The total time you'll be involved in the study, from your first visit to your final follow-up, will be clearly explained by the study team.

Potential risks and benefits

The main benefit of taking part is contributing to medical science and helping to develop new drug options. There are no direct personal health benefits as this study is for healthy volunteers. Potential risks include side effects from ticagrelor, such as bruising or bleeding, and discomfort from blood draws. All procedures will be performed by trained staff, and you'll be closely monitored. You are completely free 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.

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Unverified
Poland

Common questions

What is ticagrelor used for?

Ticagrelor is a medicine that helps prevent serious heart problems like heart attacks, especially in people who have had them before or are at high risk.

What does 'bioequivalence' mean?

It means we're checking if a new version of a medicine works in your body in the same way as an existing version, by comparing how much and how quickly it's absorbed.

Will I get the new capsule or the tablet?

You'll get both! In this study, you'll take the new capsule at one time and the standard tablet at another time, so we can compare them directly in you.

Do I have to be sick to join?

No, quite the opposite! This study is for healthy adult volunteers to understand how the medicine works without other health conditions influencing the results.

How long will I be involved?

The study team will tell you the exact time commitment, including visits and follow-ups. It involves a couple of dosing periods and health checks.