Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing apixaban 5 mg hard capsules (PG412 [Celon Pharma]) vs apixaban 5 mg film-coated tablets (Eliquis [Bristol-Myers Squibb]) under fasting conditions in healthy volunteers

This research is looking at a medicine called apixaban, which is used to prevent serious blood clots in people with certain heart conditions or after they've had a clot. There are two slightly different versions of this medicine: a new one called PG412 and an established one called Eliquis. This study aims to find out if PG412 acts in the body in exactly the same way as Eliquis when taken by healthy volunteers on an empty stomach. This is important to ensure that patients get the same benefit if they switch between the two. It's a key first step in checking if a new medicine works as expected.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Celon Pharma S.A.

Enrolment target

Start

13 Aug 2024

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF)with one or more risk factors such as prior stroke or transient ischaemic attack (TIA)age≥ 75 years hypertension diabetes mellitus symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)and prevention of recurrent DVT and PE in adults.

What is this study about?

Imagine you have a headache and you take a painkiller. Now imagine there's a new brand of that same painkiller. This study is a bit like that – it's comparing a new version of a blood-thinning medicine called apixaban (named PG412) with one that's already widely used (called Eliquis).

Apixaban is a very important medicine used to help prevent blood clots. These clots can lead to serious problems like a stroke if you have a heart condition called atrial fibrillation, or they can cause deep vein thrombosis (DVT) in your legs or pulmonary embolism (PE) in your lungs. This particular study wants to make sure that the new PG412 works in your body in exactly the same way as Eliquis. This is called 'bioequivalence' – it means they are effectively the same in how your body handles them.

By checking this in healthy volunteers, researchers can be confident that if PG412 is given to patients, it will have the same protective effects as Eliquis. It's a foundational step to ensure any new medicine meets high standards of safety and effectiveness for patients who need it.

Key takeaways

This study compares two versions of a blood-thinning medicine called apixaban.
It aims to check if a new version (PG412) works in the body the same as an existing one (Eliquis).
Healthy adult volunteers are needed for this early-stage testing.
Taking part involves clinic visits, taking the medicine on an empty stomach, and blood tests.
The findings will help ensure new medicines are effective and safe for patients.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or over. This study is looking for healthy people, not those with the medical conditions apixaban usually treats.

Both men and women are invited to take part. The main goal is to see how the medicine works in a general healthy adult population first.

Because this is a very early-stage study, the focus is on people who are well and not on other medications that might interfere with the results. More specific health checks will be done to make sure it's safe for you to participate.

Quick self-check

Are you 18 years old or older?
Are you generally healthy?
Are you happy to take medication on an empty stomach?
Are you able to attend clinic visits as required?
Are you prepared to have regular blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll visit the study clinic two separate times. Each time, you'll be given one of the apixaban medicines (either PG412 or Eliquis) on an empty stomach. You won't know which one you're getting first, but over the two visits, you will receive both. Researchers will take several blood samples over a period of time after you take the medicine to see how your body absorbs and processes it. There will be a 'washout' period between the two visits, which means a break to ensure the first medicine has completely left your body before you take the second one. You'll have regular medical checks throughout to ensure your safety.

Potential risks and benefits

Taking part in a study like this might have some small benefits, such as receiving free medical checks and contributing to important medical research that could help future patients. However, the main benefit is for scientific knowledge. There are always potential risks with any medicine, even in healthy volunteers. Common risks associated with apixaban include an increased risk of bleeding. You'll be closely monitored for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Poland

Common questions

What is apixaban normally used for?

Apixaban is a medicine that helps prevent blood clots. It's used for conditions like irregular heart rhythm (atrial fibrillation) to prevent strokes, and to treat or prevent deep vein clots in your legs or lungs.

Why are you looking for healthy people if the medicine is for sick people?

In these early studies, using healthy volunteers helps researchers understand exactly how the medicine works in the body without other health problems or medicines affecting the results. This makes sure it's safe and predictable before being given to patients.

What does 'bioequivalence' mean?

Bioequivalence means that two different versions of a medicine are absorbed by your body at similar rates and to similar extents. In simple terms, it means they work in the same way, delivering the same amount of medicine to your bloodstream.

Will I know which medicine I'm getting?

You won't know which version you're getting during each visit, but you will receive both the PG412 and the Eliquis versions over the course of the study at different times.

Will I be paid for taking part?

Information about compensation for your time and expenses will be discussed in full by the study team if you express interest.