Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Ibuprofen 200 mg bioequivalence study

This study is a "bioequivalence" trial, which means it's designed to see if a new version of a 200 mg ibuprofen tablet is absorbed into the body and works in the exact same way as an existing, approved ibuprofen tablet. This is a crucial step to make sure that new medicines have the same effect as older, trusted ones. It's a very early stage of testing medicines, known as a Phase I study. Participants will be healthy volunteers, and it doesn't involve treating any illness. The goal is to ensure that if a new ibuprofen becomes available, it will be just as effective and safe as what we already use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Patheon Softgels B.V.

Enrolment target

Start

10 Sep 2024

not applicable (submitted trial is BE)

What is this study about?

Imagine you have a headache and take an ibuprofen tablet. This study is about making sure that if a new company makes an ibuprofen tablet, it works just as well and safely as the one you're used to. Researchers need to prove that the new tablet delivers the same amount of medicine to your body at the same speed as the original.

This type of research is called a "bioequivalence study." It's not about finding a new cure or treating an illness; it's about checking quality. Think of it like comparing two identical cars from different manufacturers – you want to know they both perform the same way on the road.

By taking part, you would be helping to ensure that when new medicines become available to the public, they are reliable and effective. It’s a really important step in guaranteeing the safety and quality of medications we all might use.

Key takeaways

Checks if a new ibuprofen works like an existing one.
For healthy adults, not treating an illness.
Involves taking ibuprofen and giving blood samples.
Helps ensure future medicines are safe and effective.
Participants can leave the study at any time.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned. Both men and women can join.

Because this study is about how your body handles medication, it's very important that you are generally healthy. This means you shouldn't have any major ongoing health problems or be taking other medications that could affect the results.

Specific details about your health and any medications you currently use will be carefully checked by the study doctors to make sure it's safe and appropriate for you to participate.

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 able to attend several clinic visits?
Are you comfortable with having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given a 200 mg ibuprofen tablet, either the new version being tested or an existing one, usually on different occasions. You'll visit a clinic or hospital several times, often for a few hours, or perhaps even for an overnight stay or two.

During these visits, doctors and nurses will take blood samples regularly to measure how much ibuprofen is in your body over time. They might also check your blood pressure, heart rate, and temperature. You won't be told if you're taking the new or existing ibuprofen until the study is over.

There won't be many follow-up appointments after you've taken the medicine, as the main focus is on how it's absorbed right away. The total time you're involved could range from a few days to a few weeks, depending on the study's exact schedule, with periods of rest in between visits.

Potential risks and benefits

Taking part in a study like this helps improve our understanding of medicines, ensuring new versions are safe and effective for everyone. You might also receive payment for your time and inconvenience. However, there are potential risks, including side effects from ibuprofen (like stomach upset or headaches), discomfort from blood tests, and the inconvenience of study visits. Remember, you can always change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Czechia

Common questions

What is ibuprofen?

Ibuprofen is a common painkiller and anti-inflammatory medicine often used for headaches, muscle aches, or period pain.

What does 'bioequivalence' mean?

It means the study is checking if a new medicine works in exactly the same way as an older, trusted one in your body.

Will I get better if I join this study?

This study isn't designed to treat an illness, but to check how a medicine works in healthy people. You won't be getting 'treatment' in the usual sense.

Will I know if I'm taking the new ibuprofen or the old one?

Often in these studies, participants don't know which version they receive until after the study is completely finished, to keep the results fair.

Do I have to pay to join the study?

No, you will not have to pay to join the study. In fact, participants often receive a payment to cover their time, travel, and any inconvenience.