Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, crossover bioequivalence clinical trial of apixaban 5 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions

This study is looking at a medicine called apixaban, which is used to prevent and treat blood clots (thromboembolism). You might know it by its brand name, Eliquis. The main goal is to compare a new version of the 5 mg apixaban tablet with the original Eliquis tablet. Researchers want to make sure both tablets deliver the same amount of medicine into the body at the same speed. This is important to ensure any new version works just as well and safely as the original. This is a very early-stage study involving healthy volunteers, not patients, to check how the body handles the medicine when taken by mouth on an empty stomach.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Alter Farmacia S.A.

Enrolment target

Start

02 Jun 2023

thromboembolism

What is this study about?

This research is a 'bioequivalence' study, which means it compares two versions of the same medicine to see if they are absorbed into the body in the same way. The medicine in question is apixaban, often sold under the brand name Eliquis. It's a very important drug because it's used to prevent and treat serious conditions caused by blood clots, like deep vein thrombosis or pulmonary embolism. Ensuring different versions of this medicine work identically is crucial for patient safety and effectiveness.

In this study, healthy volunteers will take a single dose of either the original Eliquis tablet or a new version of the apixaban tablet. The main goal is to measure how much of the medicine gets into the bloodstream and how quickly. This helps researchers confirm that both tablets are absorbed at a similar speed and to a similar extent, meaning they should have the same effect on the body.

This is a 'Phase I' study, which means it's one of the first steps in testing a new medication or a new version of an existing one in humans. It focuses on safety and how the body handles the drug, rather than how well it treats a disease. The findings are vital to make sure that any new apixaban tablet works just as effectively and safely as the established one.

Key takeaways

This study compares how two versions of apixaban tablets are absorbed by the body.
It involves healthy volunteers aged 18 and over.
Participants will get a single dose of apixaban on an empty stomach.
Blood samples will be needed to measure medicine levels.
The study helps ensure new medications are effective and safe.

Who may be eligible?

To be considered for this study, you need to be a healthy adult who is at least 18 years old. There's no upper age limit mentioned, so older adults may also be able to take part if they are otherwise healthy.

This study is open to both men and women. The most important requirement is that you must be in good general health, as confirmed by medical checks from the study team. They'll want to make sure you don't have any medical conditions that could make taking the study medication unsafe or affect the results.

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?
Are you willing to take a single dose of apixaban?
Are you able to follow fasting instructions for the study?
Are you comfortable with having multiple blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be giving a single dose of either the original Eliquis tablet or a new apixaban tablet at the study clinic. This will happen on two separate occasions, with a break in between, meaning you'll get both medicines at different times (this is called a crossover study). You'll take the medicine on an empty stomach.

After taking the medicine, the study team will take several blood samples over a set period. These samples will help them measure how much apixaban is in your blood at different times. That's the main way they'll check how your body has absorbed the medicine. You will also have medical checks before and after to ensure you remain well. The total duration of your involvement, including both medication periods and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, the main benefit is contributing to medical knowledge, helping to ensure that new versions of important medicines like apixaban are just as safe and effective as the original. However, there are no direct health benefits to you personally, as it's not a treatment study. Potential risks include discomfort from blood draws, possible temporary side effects from the single dose of apixaban (even in healthy people, blood thinners carry a small risk of bleeding, though this is carefully monitored), and the time commitment. You are 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
Spain

Common questions

What is apixaban and what is it used for?

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

Why are you doing this study?

We are comparing two different versions of apixaban tablets to make sure they work exactly the same way in the body. This helps us ensure consistency if a new version is introduced.

Who can take part in this study?

This study is for healthy men and women aged 18 years and older. You must be in good general health to be considered.

Will I get the actual medicine for blood clots?

Yes, you will receive a single dose of a 5 mg apixaban tablet on two separate occasions during the study, but it's not for treating a condition, it's for research purposes.

What does 'fasting conditions' mean?

It means you won't be able to eat or drink anything (except plain water) for a certain period before and after taking the study medicine, as food can affect how medicines are absorbed.