A Single Dose, Fasting state, Crossover Replicate Bioequivalence Study of Naproxen 500 mg/Esomeprazole 20 mg, modified-release tablets (Antibiotice S.A.) vs. Vimovo® 500 mg/20 mg film-coated tablets (Grunenthal Gmbh)
This study is looking at a new version of a medicine that combines naproxen (a painkiller) and esomeprazole (a stomach protector). Researchers want to see if this new tablet, made by Antibiotice S.A., works in the human body in the exact same way as an existing tablet called Vimovo, made by Grunenthal Gmbh. To do this, healthy volunteers will take both medicines at different times. The main goal is to ensure that the new tablet delivers the active ingredients to the body at the same speed and in the same amounts as the established medicine. This is a common and important step to make new medicines available.
At a glance
What is this study about?
This research study is about comparing two different versions of the same medicine. The medicine contains two active ingredients: naproxen, which is a type of painkiller often used for conditions like arthritis, and esomeprazole, which helps protect your stomach from irritation that painkillers can sometimes cause.
The study wants to find out if a new tablet (made by a company called Antibiotice S.A.) works in your body in exactly the same way as an existing, approved tablet called Vimovo (made by Grunenthal Gmbh). This process is called a 'bioequivalence' study. It's a standard and crucial step to ensure that when a new version of a medicine is made, it's just as safe and effective as the original one people are already using.
To make this comparison, healthy volunteers will take one tablet, and then at a later time, they will take the other tablet. This allows the researchers to directly compare how each medicine behaves in the same person. They will then measure how much of the medicine gets into the bloodstream and how quickly. This helps confirm that the new and existing tablets are interchangeable and work in the same way for patients.
Key takeaways
- This study compares a new painkiller/stomach protector combination pill with an existing one.
- It aims to confirm the new pill works the same way in the body as the established one.
- Only healthy adults aged 18 and over can participate.
- You will take both medicines at different times to allow for comparison.
- Participation involves clinic visits and blood tests.
- The study helps ensure new medicines are safe and effective.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health and not have any serious ongoing medical conditions.
Specifically, you need to be at least 18 years old. There isn't an upper age limit mentioned, but participants will need to be well enough to complete the study safely.
Both men and women are welcome to participate. The study is designed for people who don't have any major illnesses that could affect how the medication works or how they respond to it.
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 serious medical conditions?
- Are you 18 years old or older?
- Are you comfortable having regular blood tests?
- Are you able to follow specific instructions about fasting and taking medicines?
- Are you able to attend clinic visits as required?
What does participation involve?
If you decide to take part, you would be asked to visit the research clinic on several occasions. You'll switch between taking the new study medication and the existing approved medication at different times. This is called a 'crossover' design, and it helps researchers compare the two medicines in the same person.
During your visits, medical staff will take blood samples at specific times after you've taken the medicine. This is how they measure how much of the medicine is in your body. You'll likely be asked to fast (not eat or drink anything except water) before taking the medication on study mornings, as this can affect how medicines are absorbed. The total time you'd be involved in the study, including all visits and follow-up, would be fully explained before you agree to participate.
Potential risks and benefits
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Common questions
What does 'healthy subjects' mean?
It means the study is looking for people who don't have any major health problems or long-term illnesses.
What is naproxen and esomeprazole used for?
Naproxen is for pain and inflammation, while esomeprazole helps protect your stomach from any irritation caused by the naproxen.
Will I know if I'm taking the new medicine or the existing one?
Yes, in a crossover study like this, you will take both types of medicine, but at different times, and the research team will explain the schedule.
Why is it important to compare new medicines to old ones?
It ensures that any new version of a medicine works just as well and is just as safe as medicines that are already approved and widely used.
Do I have to pay to be in the study?
No, you should not have to pay to participate in a clinical trial. Sometimes you may even be compensated for your time and travel.
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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