Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

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 fasting conditions.s.

This research is a 'bioavailability study' to compare how two different versions of a painkiller called naproxen sodium are absorbed by the body. One is a new test product, and the other is an existing product called Actromadol, both in a 660 mg modified-release tablet form. We want to see if the new medicine gets into your bloodstream in the same way and at the same rate as the established one. This is important to ensure that the new medicine will be just as effective and safe. The study involves healthy adult men and women, who will take the medicines after not eating for a while (fasting conditions). It’s a carefully designed study where each participant tries both medicines at different times, so we can directly compare them within the same person.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Cinfa S.A.

Enrolment target

Start

09 Dec 2025

Bioavailability study in healthy volunteers under fasting conditions.

What is this study about?

This study is all about understanding how a new pain relief tablet, containing naproxen sodium, works inside your body compared to a familiar one. It's called a 'bioavailability' study, which simply means we're checking how much of the medicine gets into your bloodstream and how quickly. This is crucial because it helps us tell if a new version of a drug will work just as well as an existing one.

Imagine you take a painkiller for a headache. For it to work, the medicine needs to be absorbed from your stomach and enter your blood, from where it travels to where the pain is. In this study, we're comparing a new naproxen sodium tablet to an established one to make sure they both deliver the medicine to your body in a very similar way. This ensures that the new tablet will be just as effective at relieving pain.

The study is done under 'fasting conditions,' meaning you wouldn't eat before taking the medicine. This helps scientists get a clear picture of how the medicine is absorbed without food interfering. It also means that healthy adult volunteers are needed for this type of research, as it helps us understand the basic way the medicine works without other health conditions complicating the results.

Key takeaways

This study compares a new naproxen sodium tablet with an existing one.
It checks how well the medicine is absorbed into the body (bioavailability).
Participation involves healthy adult men and women.
You'll need to fast (not eat) before taking the medicine during study visits.
Each participant tries both medicines over different periods.
Your health will be monitored, and blood samples will be taken throughout.

Who may be eligible?

To be able to take part in this study, you need to be a healthy adult who is at least 18 years old. There's no upper age limit, as long as you're in good general health.

Both men and women can participate. Being healthy means you don't have any significant medical conditions that might affect how your body handles the medicine or make taking part unsafe for you. You'll have a health check to make sure you're suitable.

Because this is a 'fasting' study, you'll need to be able to go without food for specific periods before and during each study visit. All these details will be explained fully if you decide to find out more.

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 in good health?
Are you able to go without food for specific periods?
Are you comfortable with regular blood tests?
Are you available for multiple study visits over a period of time?
Have you fully understood the commitment involved?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in a 'crossover' study design. This means at different times, you'll try both the new naproxen sodium tablet and the existing one. For each 'period' of the study, you'll come to the clinic after not eating (fasting).

During your visits, medical staff will check your health and probably take blood samples at different times after you've taken the study medicine. This is to measure how much of the medicine is in your bloodstream. You'll likely stay at the clinic for a good part of the day, or perhaps overnight, during these periods. There will be a 'washout' period between taking the two different medicines, meaning a break to ensure one medicine has left your system before you start the next. The total length of your involvement, from your first screening visit to your last follow-up, will be clearly explained beforehand.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, a benefit is contributing to medical science and helping to ensure new medicines are effective and safe for future patients. You will also receive careful medical monitoring during your participation. Potential risks could include side effects from the study medication, discomfort from blood draws, or the inconvenience of study visits. All potential side effects of naproxen sodium will be fully explained. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is 'naproxen sodium'?

Naproxen sodium is a common medicine used to relieve pain, reduce fever, and lessen inflammation, often found in over-the-counter and prescription pain relievers.

What does 'modified release' mean?

Modified release means the tablet is designed to let the medicine out slowly over time, rather than all at once. This can mean you don't have to take it as often.

Why do I have to fast?

Fasting helps scientists get a clear and consistent measurement of how the medicine is absorbed into your body without food affecting the results. It's a standard part of these types of studies.

Is this a new type of medicine?

This study is comparing a 'test product' (a new version) of naproxen sodium with an 'existing' product. So, the medicine itself isn't entirely new, but the way it's formulated might be.

Will I get paid for taking part?

The study information will detail if there is any payment for your time, travel expenses, or other reimbursements. This will be explained to you before you agree to take part.