Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Apixaban 5 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions.

This study is checking if a new version of the blood-thinning medicine called apixaban works just like the original one. It focuses on healthy volunteers and measures how the medicine gets into their bodies when they haven't eaten. This type of study, called a bioequivalence study, is important to make sure that new versions of existing medicines are just as safe and effective. It's a very early-stage study, meaning it's one of the first steps in testing a new medicine in people. People who are generally healthy and aged 18 or over, male or female, can take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Cinfa S.A.

Enrolment target

Start

11 Dec 2023

No medical condition.

What is this study about?

This study is looking at a medicine called apixaban, which is used to thin the blood. It helps prevent serious problems like blood clots. When new versions or 'generic' versions of existing medicines are made, it's really important to make sure they work exactly the same way as the original. This is what this study aims to find out for a new apixaban tablet.

Imagine you have two different brands of a popular painkiller, like paracetamol. This study is similar: it's checking if a new version of apixaban gets absorbed into the body and reaches the same levels in the blood as the original apixaban tablet. This is called 'bioequivalence'. If they are 'bioequivalent', it means they work in the same way and are just as good. This study is done in healthy people because we want to see how the medicine acts in the body without any other medical conditions complicating things.

Finding new ways to make medicines, perhaps making them more affordable or easier to access, is very important. Studies like this help ensure that any new version of a trusted medicine is just as reliable as the one we're used to. It's a key step in bringing safe and effective new medicines to people who need them.

Key takeaways

This study compares a new apixaban tablet with the original.
It's checking if both tablets work the same way in the body.
It involves healthy volunteers (age 18+).
Participation includes taking medicine and giving blood samples while fasting.
Your involvement helps bring new medications to patients safely.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part. There is no upper age limit, meaning older adults can also participate.

Both men and women are welcome to join this study. You don't need to have any specific medical condition or illness to be eligible. In fact, it's important that you are generally healthy, as the study wants to see how the medicine works in people without other health issues.

More detailed checks will be done by the study team, but generally, if you're an adult who is in good health and not currently taking many medications (especially blood thinners), you might be suitable.

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 able to fast (not eat) for periods?
Are you comfortable with giving blood samples?
Are you not currently taking blood-thinning medications?

Answer every question to see your result.

What does participation involve?

The information provided is quite brief on participation, but typically, a bioequivalence study involves several visits to a clinic. You would likely be asked to take the study medicine (apixaban or the new version) after a period of not eating (fasting). Blood samples would be taken regularly over several hours to measure levels of the medicine in your body. This process might be repeated on a different day with the other version of the medicine to compare them. Each visit could last for a full day. The total duration of your involvement could range from a few days to a few weeks, including screening appointments and follow-up.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science and helping to make new versions of medicines available. You would also receive health checks. Potential risks could include side effects from the study medicine, such as bleeding or bruising, as apixaban is a blood thinner. There might also be discomfort from blood draws. You will be monitored closely by medical staff. Remember, you can decide to stop participating in 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
Portugal

Common questions

What is apixaban?

Apixaban is a medicine used to prevent blood clots, often prescribed for conditions like atrial fibrillation or after certain surgeries.

Why is this study done in healthy people?

It's done in healthy people so researchers can see exactly how the medicine acts in the body without other illnesses making the results complicated.

What does 'fasting conditions' mean?

It means you will be asked not to eat or drink anything (except water) for a certain number of hours before taking the study medicine.

What is a 'bioequivalence' study?

It's a study that checks if a new version of a medicine works in the same way and is absorbed into the body in the same amounts as an original, approved medicine.

Will I get paid for taking part?

Often, studies involving healthy volunteers offer payment for time, travel, and inconvenience. You should ask the study team about this.