Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

RANDOMISED, CROSSOVER BIOEQUIVALENCE CLINICAL TRIAL OF APIXABAN 5 MG CAPSULES VS APIXABAN 5 MG FILM-COATED TABLETS, AFTER A SINGLE ORAL DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS UNDER FASTING CONDITIONS

This research is looking at a medicine called apixaban, which is used to prevent and treat blood clots (thrombosis). You might know it by the brand name Eliquis. The study wants to check if a new capsule form of 5mg apixaban works in exactly the same way as the already approved 5mg tablet. We're testing this in healthy volunteers who take a single dose on an empty stomach. This type of study, called a bioequivalence study, is important because it helps ensure that any new version of a medicine is just as safe and effective as the original. It’s a standard step in bringing new medicines to people who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Alter S.A.

Enrolment target

Start

11 Aug 2023

thrombosis

What is this study about?

This study is designed to compare two different ways of taking the blood-thinning medicine apixaban. Apixaban is commonly used to prevent and treat serious conditions like thrombosis, which involves blood clots forming in your veins. You might know it as Eliquis. One form is the regular tablet you can already get, and the other is a new capsule form.

The main goal is to see if the new capsule form delivers the medicine into your body in the same way and at the same speed as the tablet. This is really important because if a new version behaves differently, it might not work as well or could have different side effects. By testing this in healthy volunteers, researchers can ensure that any new medicine approved for wider use will be just as effective and safe as the one doctors already prescribe.

This type of study is called a 'bioequivalence study' and is a standard and necessary step in checking new drug formulations. It helps regulatory bodies, like the NHS in the UK, to be confident that patients will get the same reliable treatment, regardless of which form of the medication they receive.

Key takeaways

This study compares different forms of the blood-thinning medicine apixaban (Eliquis).
It aims to ensure a new capsule form works the same as the existing tablet.
Healthy adult volunteers are needed for this research.
Participation involves taking single doses of each medicine form and giving blood samples.
You'll be fasting before taking the medication.
It's a standard and safe way to test new drug formulations.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be at least 18 years old.

Both men and women are welcome to participate. The researchers will be looking for people who are generally well and don't have any major ongoing health problems, as the study is focused on how the medicine works in a typical, healthy body.

There will be specific health checks and questions to ensure it's safe for you to take part. For example, they'll need to know about any medicines you currently take or any allergies you might have. These checks are always done to protect your safety during 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 with no major ongoing health problems?
Are you comfortable with taking blood samples?
Are you able to fast (not eat) for specific periods?
Are you able to attend several clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of either the apixaban tablet or the apixaban capsule on different occasions. This is called a 'crossover' study, meaning you'll get both and act as your own comparison. You'll need to take the medicine on an empty stomach, so fasting beforehand will be required.

During each visit, blood samples will be taken at specific times after you've taken the medicine. These blood samples help the researchers measure how much apixaban is in your body and how quickly it's absorbed and then leaves your system. There might also be other routine health checks, like blood pressure measurements.

Because you'll be taking two rounds of medication (one tablet, one capsule, with a break in between), you'll likely have a few visits to the study clinic. The total time you'd spend involved, from your first visit to your last follow-up, will be explained in full detail by the study team.

Potential risks and benefits

A potential benefit of taking part in studies like this is helping to bring new and potentially improved medicines to patients in the future. You'd also contribute valuable scientific knowledge. As for risks, since this is a healthy volunteer study, the potential risks are generally low. However, taking any medication, even a single dose, carries some very small risks, such as mild side effects like dizziness or an upset stomach, or potential reactions specific to apixaban or the procedures (e.g., bruising from blood draws). All procedures and potential side effects will be fully explained before you agree to participate. Remember, your participation is voluntary, and you have the right 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
Spain

Common questions

What is thrombosis?

Thrombosis is a medical term for when a blood clot forms inside a blood vessel, which can block the flow of blood. It can be serious if not treated.

What is apixaban?

Apixaban is a medicine, often known by the brand name Eliquis, that helps to thin your blood. It's used to prevent and treat blood clots.

Whycompare a tablet and a capsule?

Researchers want to make sure that a new medicine form, like a capsule, works in exactly the same way as the existing tablet. This ensures it's just as safe and effective for patients.

What does 'fasting conditions' mean?

It means you will need to not eat or drink anything (except plain water) for a certain period before taking the medicine. This helps ensure accurate results.

Will I receive any payment for taking part?

Compensation for your time and travel expenses is often provided for studies like this. The study team will give you all the details.