A Single Dose, Fed state, Crossover Replicate, Bioequivalence Study of Naproxen 500 mg/ Esomeprazole 20 mg modified-release tablets (Antibiotice S.A.) versus Vimovo® 500 mg/20 mg film coated tablets (Grunenthal GmbH)
This study is looking at a new version of a medication that combines two drugs: naproxen and esomeprazole. Naproxen is a pain reliever often used for conditions like arthritis, and esomeprazole helps protect your stomach. The new tablet is made by a company called Antibiotice S.A., and we're comparing it to a well-known existing medicine called Vimovo®. The main goal is to check if the new tablet acts in the body in the same way as Vimovo. This is called a "bioequivalence" study. If they are bioequivalent, it means the new tablet should have the same benefits and safety as the original.
At a glance
What is this study about?
Imagine you have a headache, and you take a painkiller. That painkiller has to break down in your body and get into your bloodstream to start working. This study is testing a new combined tablet that includes two medicines: naproxen and esomeprazole. Naproxen is a common pain relief medicine, often used for problems like arthritis or muscle aches. Esomeprazole is a medicine that helps reduce stomach acid, which can protect your stomach lining, especially important when taking pain-relieving medicines regularly.
The main purpose of this study is to see if this new combined tablet works in your body in exactly the same way as a very similar medicine already available, called Vimovo®. This is like checking if two different brands of a popular drink taste the same and give you the same refreshing feeling. Researchers want to make sure that the new tablet delivers the medicines to your body at the same speed and in the same amounts as the existing one. This means that if you were to take the new tablet, you should expect to get the same effects as if you took Vimovo®.
This type of study is called a 'bioequivalence' study. It's an important step for any new medicine that is similar to one already on the market. If the new tablet is found to be 'bioequivalent', it means it's considered to be just as safe and effective as the original. This is good news because it can mean more choices for patients and potentially more affordable medications in the future. This particular study is being done in healthy volunteers.
Key takeaways
- The study compares a new combined pain and stomach protection tablet to an existing one.
- It aims to confirm the new tablet works the same way in the body as the original (Vimovo®).
- Participation is for healthy adults, aged 18 and over.
- It involves taking both medicines at different times and close monitoring.
- Your contribution helps ensure new medicines are safe and effective.
- You can stop participating at any time.
Who may be eligible?
This study is looking for healthy people to take part. You must be at least 18 years old.
Both men and women can participate in this study. The most important thing is that you are generally healthy, as the study needs to accurately compare how the different medicines work without other health conditions affecting the results.
There isn't an upper age limit mentioned, but you would still need to be healthy, as assessed by the study doctors, to be eligible.
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 healthy?
- Are you comfortable having regular blood samples taken?
- Are you able to commit to several visits to a clinic over a few weeks?
- Are you not currently taking other strong medications that could interfere with the study?
What does participation involve?
If you join this study, it's called a 'crossover replicate' study. This means you will receive both the new medicine and the existing medicine (Vimovo®) at different times, with a break in between. This helps compare them directly within the same person.
Each time you take a medicine, you'll be monitored closely. This usually involves spending time at the clinical research unit, having blood samples taken regularly to measure how the medicine moves through your body, and having your general health checked. You will take one dose of the medicine at a time. The study will involve several visits to the clinic, usually over a few weeks or months, as you'll switch between taking the different medicines. The total duration of your involvement, including all visits and follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is naproxen and esomeprazole?
Naproxen is a type of pain reliever, often used for aches and pains. Esomeprazole is a medicine that helps reduce stomach acid to protect your stomach.
What does 'bioequivalence' mean?
It means we're checking if a new medicine works in your body in the same way, at the same speed and amount, as an existing, approved medicine. If they are 'bioequivalent', it means they are expected to have the same effects.
Why are you doing this study on healthy people?
Testing on healthy people helps us clearly see how the medicines work in the body without other health conditions affecting the results. This makes the comparison between the old and new medicines more accurate.
Will I get paid for taking part?
Most studies like this offer some payment or reimbursement for your time, travel, and inconvenience. The study team will be able to give you specific details.
Is this a new type of medicine?
No, it's a new version of an existing combined medicine (naproxen and esomeprazole) that is already available as Vimovo®. The study is to see if the new version is just as good.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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