AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Tramadol retard 200 mg Prolonged-Release Tablets in Healthy Subjects Under Fed Conditions

This research study is looking at a specific type of pain medicine called Tramadol 200mg, which is designed to release slowly into your body over time. The main goal is to see if a new version of this slow-release tablet, known as a 'prolonged-release' tablet, behaves in the same way as an already approved version when people take it with food. This kind of study is called a 'bioequivalence' study. It helps ensure that new medicines, even if they look slightly different, work exactly the same as the originals, so patients get the same pain relief safely. Healthy adult volunteers are taking part to help us understand how the body handles this medicine.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Cinfa S.A.

Enrolment target

Start

04 Jun 2026

Not applicable (submitted trial is a bioavailability trial in healthy participants).

What is this study about?

This study is all about a common pain medicine called Tramadol, specifically a 200mg tablet that's designed to release its effects slowly over a longer period. You might have heard these called 'slow-release' or 'modified-release' tablets. The main purpose of this research is to check if a newly made version of this tablet works in exactly the same way as one that's already approved and used by patients. It's like comparing two different brands of the same product to make sure they both do the job equally well.

Researchers want to carefully observe how the body handles this new Tramadol tablet when it's taken with food. They'll be looking at how much of the medicine gets into the bloodstream and how quickly. This is really important because taking medicine with or without food can sometimes change how it works in your body. By doing this, they can ensure that the new tablet will be just as effective and safe as the existing one for future patients.

This type of study is specifically for understanding how a new medicine acts in the body, rather than testing its effects on a specific illness. It's a crucial early step in bringing medicines to patients, ensuring that any new version of an approved medicine is just as reliable and predictable as the original. It helps medical professionals make sure that patients will always get the right amount of medicine at the right time, regardless of which manufacturer made their particular tablet.

Key takeaways

This study compares a new slow-release Tramadol tablet with an existing one.
The main goal is to ensure the new tablet works identically to the original when taken with food.
Healthy adult volunteers are participating to see how the medicine acts in the body.
It's a crucial step to make sure new medicines are safe and effective.
Participants will have regular health checks and blood tests.

Who may be eligible?

This study is looking for healthy adults to take part. This means we're looking for men and women aged 18 years or older who are generally well and don't have any major ongoing health problems.

Because this is a study about how a medicine acts in the body, it won't be looking for people with specific illnesses. Instead, the focus is on a group of people who are in good health. This helps the researchers understand how the medicine behaves without other health conditions getting in the way.

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 with no major ongoing illnesses?
Are you able to attend several clinic visits?
Are you comfortable with taking medication and having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the Tramadol 200mg prolonged-release tablets to take with food. The study involves several visits to the clinic, where doctors and nurses will monitor you closely. They'll take blood samples at different times after you've taken the medicine to measure how much of it is in your body. There will also be other health checks throughout the study to make sure you remain well. The total duration of your involvement in the study, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking part in this particular study, as its main goal is to gather information for future patients. However, your involvement contributes to valuable scientific knowledge that helps ensure safe and effective medicines are available. Potential risks could include side effects from the medication (like feeling sick or dizzy, which are common with Tramadol) and discomfort from blood draws. You will be closely monitored by medical staff for any reactions. Remember, you can ask questions at any time and have the right to withdraw from the study at any point without giving a reason, and it won't affect any future 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 Tramadol used for?

Tramadol is a type of painkiller often used to treat moderate to severe pain. It's available in different forms, including tablets that release the medicine slowly.

What does 'prolonged-release' mean?

Prolonged-release means the tablet is designed to let the medicine out into your body slowly over a longer period. This means you don't have to take it as often and get more steady pain relief.

Why is it important to take the medicine with food in this study?

Taking medicine with food can sometimes change how your body absorbs it. This study specifically checks if the new tablet works the same as the old one when taken with food, ensuring it's safe and effective under these common conditions.

Will I know if I'm getting the new tablet or the existing one?

The study design will be explained to you in full. Often in these studies, participants might receive either the new or existing tablet, or sometimes both at different times, without knowing which, to ensure fair comparison. This is called 'blinding'.

Who is funding this study?

The study is funded by the company developing the new version of the Tramadol tablet. This is common practice in medical research to get new medicines approved.