Single-center, single-dose, open-label, laboratory-blinded, randomized, two-treatment, two-period bioequivalence (BE) study comparing the Test Product Apixaban 5 mg film-coated tablets (MEDITOP) with the Reference Product Eliquis 5 mg film-coated tablets (Bristol-Myers Squibb/Pfizer) under fasting conditions.
This research is a study looking at two different brands of apixaban 5mg tablets. Apixaban is a medicine used to prevent and treat blood clots. The main goal is to see if a new generic version of apixaban (called the Test Product) acts the same way in the body as the original, well-known brand, Eliquis. This is important to make sure that generic medicines are just as effective and safe. Healthy adult volunteers will take a single dose of each medicine on separate occasions, without having eaten beforehand. Researchers will then check how the medicine is absorbed and processed by the body. This type of study is called a bioequivalence study and is an early stage of drug development.
At a glance
What is this study about?
This research study is focused on a medicine called apixaban, which is used to prevent and treat blood clots. When new generic medicines are developed, it’s really important to prove they work in exactly the same way as the original brand-name drug. That's what this study is all about.
The researchers are comparing a new generic 5mg apixaban tablet (the "Test Product") with the established brand-name 5mg apixaban tablet, Eliquis. They want to make sure that the generic version is absorbed into the body at the same speed and to the same extent as Eliquis. If they are very similar, we say they are "bioequivalent," meaning they are expected to have the same medical effects.
This study is being done with healthy volunteers. They will be given a single dose of each medicine on different days, making sure they haven't eaten recently (this is called "fasting conditions"). By doing this, the scientists can accurately measure how the medicine gets into the bloodstream. This type of study is part of the early stages of testing a new generic medicine, making sure it’s suitable for wider use.
Key takeaways
- Compares a new generic apixaban with the original Eliquis.
- Aims to check if they work the same way in the body.
- Involves healthy adult volunteers, aged 18 and over.
- Participants will follow fasting rules before taking medication.
- Multiple clinic visits will be needed for medication and blood samples.
- Your participation helps bring new generic medicines to market.
Who may be eligible?
This study is looking for healthy adults to take part. Generally, if you are 18 years old or older, you might be able to join. Both men and women can participate in this study.
To be considered healthy, it means you don't have any serious ongoing medical conditions, and you're not taking medications that might interfere with how this study works. All volunteers will need to undergo a health check-up to make sure they are suitable and that participating would be safe for them.
More detailed health criteria will be discussed by the study team, so even if you feel healthy, there might be specific reasons you cannot join. This is always to protect your safety.
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?
- Do you consider yourself to be in good general health?
- Are you able to follow specific instructions, like fasting?
- Are you comfortable with having regular blood samples taken?
- Can you commit to attending multiple visits at the study clinic?
What does participation involve?
If you decide to take part in this study, you would visit the study clinic multiple times. On each visit, you would be given a single dose of one of the study medications (either the new generic apixaban or Eliquis).
Before taking the medicine, you would need to fast, meaning you wouldn’t be allowed to eat for a certain period. After taking the medicine, blood samples would be collected regularly over a set number of hours. These samples help researchers measure how the medicine moves through your body. You might also have other checks, like blood pressure or heart rate measurements, during your visits.
There will be at least two main study periods where you receive medication, separated by a 'washout' period to ensure the first dose has left your system. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail by the study team.
Potential risks and benefits
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Common questions
What is apixaban?
Apixaban is a medicine commonly prescribed to help prevent and treat blood clots in your body.
Why are you doing this study?
We are comparing a new generic apixaban tablet with an existing brand (Eliquis) to make sure they work the same way in the body.
Who can join this study?
We are looking for healthy adults, aged 18 and over, both men and women. You will have a health check to confirm you are suitable.
What does 'fasting conditions' mean?
It means you will not be allowed to eat food for a specific amount of time before taking the study medication, usually overnight.
Will I get paid to take part?
Compensation for your time and travel expenses is usually provided for studies like this. The study team will give you full details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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