Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

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

This study is comparing a new version of a medicine called apixaban (also known as Eliquis) with the original one. Apixaban is a drug used to prevent blood clots. We want to check if the new version works in exactly the same way as the original when taken by healthy adult volunteers. Each volunteer will take a single dose of both medicines at different times. Researchers will then measure how much of the medicine gets into the body and how quickly, to ensure the new version is just as effective and safe as the original. This is a common and important step when new versions of existing medicines are developed.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

27 Mar 2023

Healthy volunteers

What is this study about?

This study is looking at a medicine called apixaban. You might know it by its brand name, Eliquis. Apixaban is a common medicine prescribed to help prevent blood clots, which can be very serious. When a medicine's patent runs out, other companies can make their own versions, often called 'generic' medicines. These generic versions are usually much cheaper, making healthcare more affordable and accessible.

However, before a generic medicine can be used, it needs to be thoroughly checked. This study, called a 'bioequivalence' study, is designed to confirm that a new generic version of apixaban works in exactly the same way as the original Eliquis tablet. 'Bioequivalence' simply means that the two products are the same in terms of how much medicine gets into your blood and how quickly.

By carefully measuring how the medicine behaves in the body after healthy volunteers take it, scientists can make sure that the new generic apixaban will have the same benefits and safety profile as the original. This is a vital step to ensure that people can switch to a more affordable version without any worries about their treatment being less effective.

Key takeaways

This study compares a new apixaban medicine with the original to ensure they work the same.
It's for healthy adults aged 18 and over, both men and women.
Participants will take both medicines (original and new) on an empty stomach at different times.
Blood samples will be taken frequently to see how the medicine acts in the body.
This research helps make essential medicines more affordable and widely available.

Who may be eligible?

This study is looking for healthy adult volunteers. This means you should not have any long-term medical conditions or be taking regular medication for an illness. The main aim is to see how the apixaban medicine works in a healthy body, without other health issues affecting the results.

To join, you need to be at least 18 years old. There is no upper age limit mentioned, but generally, participants should be fit and well enough to take part in the study procedures.

Both men and women are welcome to participate in this research. The study will likely involve screening checks to confirm your general health before you can take part.

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 generally healthy with no long-term medical conditions?
Are you at least 18 years old?
Are you not taking any regular prescription medications for an illness?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the original apixaban and a single dose of the new apixaban at different times. This type of study is 'crossover,' meaning everyone gets both treatments. Both doses would be taken on an empty stomach (fasting). Researchers would take blood samples at specific times after you take the medicine to measure how much of it is in your body. You'd likely need to stay at a special clinic for a period after each dose for these blood tests. There would also be a break period between receiving the two different medicines. The full study involves these two treatment periods and some follow-up, but the total time commitment isn't specified here.

Potential risks and benefits

The main benefit of this study is helping develop new, more affordable versions of important medicines, which contributes to public health. While taking part, you might experience mild side effects from apixaban, such as bruising or minor bleeding, as it's a blood thinner. There's also some discomfort from regular blood tests. 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 for?

Apixaban is a medicine typically used to prevent blood clots from forming in your body, which can cause serious health problems.

What does 'bioequivalence' mean?

It means we are checking if a new version of a medicine works exactly the same way as the original one in your body.

Will I have to take both medicines?

Yes, in this type of study, each participant typically receives both the original and the new version of the medicine at different times.

Do I have to be sick to join?

No, this study is specifically looking for healthy adult volunteers, meaning people without any significant ongoing health problems.

Will I be paid for participating?

The information provided doesn't specify payment, but many healthy volunteer studies offer some compensation for time and travel. You should ask about this.