Multiple-dose, open-label, laboratory blinded, randomized, 2-period, 2-sequence, crossover, steady-state bioequivalence study comparing the Test Product Naproxen sodium 660 mg modified release tablets with the Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fed conditions.
Naproxen is a widely used painkiller that helps reduce swelling, joint pain, and inflammation. This study looks at a new 'modified-release' naproxen tablet, which is designed to release medicine slowly into the body so the effects last longer. Researchers want to prove 'bioequivalence'—meaning they want to confirm that this new tablet delivers the medicine into the blood in the exact same way as an already approved brand called Actromadol. The trial is open to healthy adult men and women aged 18 and older. Volunteers will take both versions of the tablet at different times, always after eating a meal. Doctors will take regular blood tests to track how the medicine is absorbed and cleared by the body. This study helps ensure that new, potentially more affordable versions of standard medicines are just as safe and effective as existing treatments.
At a glance
What is this study about?
Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Doctors commonly prescribe it to relieve stiffness and pain caused by arthritis, back problems, and muscle injuries. Modified-release tablets are specially designed so they dissolve slowly in the gut. This steady release provides lasting relief without patients needing to take tablets several times a day.
When a healthcare company develops a new version of an established medicine, they must prove that it behaves in identical ways to the original brand. This is known as a bioequivalence study. In this trial, researchers are comparing a new 660 mg modified-release naproxen tablet against Actromadol, a licensed medicine that contains the same dose. They want to confirm that both tablets release the drug into the bloodstream at the same speed and in the same amount.
The trial is carried out in healthy volunteers who take the medicine after eating a meal. Testing in healthy individuals allows researchers to see clearly how the body processes the tablet without other medical conditions or treatments interfering. If the study shows that both tablets produce matching levels of naproxen in the blood, the new tablet can be approved as an equivalent, reliable option for patients who need long-lasting pain relief.
Key takeaways
- Tests a new slow-release naproxen tablet against an approved brand called Actromadol.
- Open to healthy adult men and women aged 18 and older.
- Aims to prove both tablets deliver the same amount of painkiller into the blood.
- Volunteers take both medicines at separate times, always after eating a meal.
- Involves clinic stays, health checks, and scheduled blood tests.
Who may be eligible?
This trial is looking for healthy men and women aged 18 and older. Because the purpose is to understand how a typical, healthy body handles the medicine, participants must generally be in good health and free from long-term illnesses.
People with a history of stomach ulcers, serious digestive conditions, or severe kidney or liver problems will not be able to take part. This is because anti-inflammatory painkillers can irritate the stomach lining. Anyone with a known allergy to naproxen, aspirin, or other NSAIDs is also excluded for safety reasons.
Women who are pregnant, planning to become pregnant, or breastfeeding will not be eligible to participate. The study team will run standard health checks before anyone joins to ensure taking part is safe for them.
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.
- I am at least 18 years old.
- I am in good general health with no major illnesses.
- I do not have a history of stomach ulcers or severe gut troubles.
- I am not allergic to naproxen, aspirin, or similar anti-inflammatory medicines.
- I am not currently pregnant or breastfeeding.
What does participation involve?
Taking part involves visiting a specialist clinical unit across two separate study periods. In one period, you will receive the new naproxen tablet, and in the other, you will receive the reference tablet, Actromadol. You will take the doses with meals over a few days so the drug reaches a steady level in your system. Between these two periods, there will be a rest break called a 'washout period' to allow the first medicine to completely leave your body. During your visits, the research team will monitor your blood pressure and heart rate, and take regular blood samples to measure drug levels. You will also have a health check before the trial begins and a follow-up assessment at the end. The total time commitment is usually several weeks.
Potential risks and benefits
Locations (1)
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Common questions
What does 'modified release' mean?
It means the tablet is specially made to dissolve slowly, releasing medicine into your body steadily over many hours.
What is bioequivalence?
It is a test to show that two different brands of the same medicine release identical amounts of active ingredient into your blood at the same speed.
Why do volunteers have to take the medicine with food?
Food can change how quickly medicines are absorbed. Taking tablets after a meal ensures everyone is tested under identical, real-life conditions.
Why are healthy volunteers used instead of people with pain?
Testing healthy people helps scientists measure how the medicine moves through the body without symptoms or other treatments confusing the results.
Will I be paid for taking part?
Phase 1 studies with healthy volunteers often provide payment to compensate you for your time and travel expenses. The study team can give you full details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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