Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the relative bioavailability of Test Product Naproxen sodium 660 mg modified release tablets to Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fed conditions.
This study is looking at a new version of a painkiller, Naproxen sodium, and comparing it to a well-known one called Actromadol. We want to check if both tablets are absorbed and work in the body in a very similar way when taken after food. This type of study, called a bioequivalence study, is crucial for developing new medications. It's for healthy adult men and women, and you won't have any medical conditions to take part. By understanding how the new tablet behaves in the body, we can help ensure that it will be an effective and safe option for pain relief in the future.
At a glance
What is this study about?
Imagine you have a headache and you take a painkiller. You want to know it will work just as well as the last one you took, even if it's a slightly different brand. That's a bit like what this study is all about. We're testing a new version of a medication that contains Naproxen sodium, a common pain reliever, and comparing it to an existing, similar tablet called Actromadol. Both tablets have the same amount of the active ingredient, 660 mg.
The main goal is to see if the new tablet delivers the medicine into your body at the same speed and to the same extent as the Actromadol tablet. This is important because it tells us if both tablets will have a similar effect on you. We specifically want to test this when people have recently eaten a meal, as food can sometimes change how medicines are absorbed.
This kind of study is called a 'bioequivalence' study. It's a standard and necessary step in developing new medicines. If the new tablet is found to be 'bioequivalent' to the established one, it means they are considered interchangeable, and you can expect similar pain relief from both. Your participation helps us ensure new medications are effective and safe for everyone.
Key takeaways
- Compares a new painkiller tablet to an existing one (Actromadol).
- Aims to check if both tablets work similarly in the body after food.
- Only for healthy adult men and women, aged 18 and over.
- Involves taking both tablets at different times and providing blood samples.
- Helps develop safe and effective new medicines.
- You can withdraw at any time without affecting your healthcare.
Who may be eligible?
This study is looking for healthy adults. This means you shouldn't have any ongoing medical conditions that could affect how your body handles the medication being studied. Your general health will be checked to make sure it's safe for you to take part.
To join, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also participate as long as they are generally healthy and meet other study requirements.
Both men and women are welcome and encouraged to participate in this study. The study aims to understand how the medication works in all healthy adults.
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 ongoing medical conditions?
- Are you 18 years old or older?
- Are you available for clinic visits and stays?
- Are you comfortable with having blood samples taken?
- Are you able to eat a standard meal before taking medication?
What does participation involve?
If you join this study, you'll be given both the new Naproxen sodium tablet and the Actromadol tablet at different times. You will stay at the study clinic for a short period after taking each tablet. Before and during your time at the clinic, your blood will be drawn several times to measure how much of the medication is in your system. This helps us understand how your body absorbs and processes the medication.
You will receive each of the two tablets on separate occasions, with a break in between. The study is designed so you will take one type of tablet, have a rest period, and then take the other type. You'll need to eat a standard meal before taking the medication on each occasion. After you've completed both parts of the study, there might be a final check-up. The total duration of your participation, including all visits and rest periods, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is the new tablet being tested?
It's a new version of Naproxen sodium, a common painkiller, and we're comparing it to Actromadol.
Why do you need healthy people for this study?
We need healthy people to clearly see how the medication works in the body without other health conditions affecting the results.
Will I receive any treatment for a medical condition?
No, this study is not for treating any medical condition. It's about understanding how medication works in healthy people.
Do I have to stay at the clinic?
Yes, you will need to stay at the clinic for a short time after taking each tablet so we can monitor you and take blood samples.
Will I take the medication on an empty stomach?
No, you will take the medication after having a meal, as this study specifically looks at how it works 'under fed conditions'.
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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