Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Evaluation of bioequivalence of two products containing 400 mg ibuprofen and 100 mg caffeine: Ibuprofen / Caffeine 400 mg / 100 mg coated granules (Test) vs. Thomapyrin TENSION DUO, 400mg / 100mg Filmtabletten (Reference). A monocentric, open, randomized, single dose, two-period, crossover trial in healthy volunteers

This research study is about comparing two different pain relief medicines that both contain 400mg of ibuprofen and 100mg of caffeine. We want to see if these two medicines are absorbed by the body in the same way and at a similar speed. This is important to ensure that new medicines work just as effectively as existing ones. The study involves healthy adult volunteers who will take a single dose of each medicine at different times. It's a simple comparison to understand how the body handles these specific drug combinations. The study is not looking to treat any health conditions, but rather to gather information about the medicines themselves.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Hermes Pharma GmbH

Enrolment target

Start

09 Aug 2024

No therapeutic indication in the current trial with healthy volunteers.

What is this study about?

Imagine you have a headache and you reach for a painkiller. You want to make sure that the medicine you take will work as expected. This study is similar to that, but behind the scenes. We're looking at two different versions of a pain relief medicine that combine 400mg of ibuprofen and 100mg of caffeine. Ibuprofen is a common painkiller, and caffeine can sometimes help it work faster.

The main goal of this study is to see if these two versions of the medicine deliver their ingredients to the body in the same way. This is called 'bioequivalence'. It's a bit like checking if two different brands of a common household product, like washing up liquid, work equally well. For medicines, it means checking that the amount of ibuprofen and caffeine that gets into your bloodstream, and how quickly it gets there, is similar for both products.

This kind of study is really important for ensuring that new medicines are just as good as older, well-established ones. We're not trying to treat any illnesses in this study. Instead, we're focusing on understanding how the medicines themselves behave inside healthy people. This helps regulators ensure that all medicines available to you are safe and effective.

Key takeaways

Compares two common pain relief medicines.
Checks if they work the same way in the body.
Only healthy adults are eligible to take part.
Involves taking single doses and blood tests.
Not a treatment study, but helps ensure medicine quality.

Who may be eligible?

This study is looking for healthy volunteers, meaning people who are generally well and don't have any major ongoing health problems. The study is open to both men and women.

To be eligible, you need to be at least 18 years old. There is no upper age limit specified, so as long as you are healthy and meet the other criteria, you can be considered.

Because this study involves taking medication, there will be careful checks to make sure it's safe for you to take part. You'll have medical checks to confirm you are healthy enough.

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 medical conditions?
Are you comfortable having blood samples taken?
Are you able to commit to the study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit a special research clinic. This is a "single dose" study, meaning you'll take each of the two different medicines just once. You won't take both at the same time. Instead, there will be a break period between taking the first medicine and the second. During your visits, you'll have blood samples taken at specific times to measure how much ibuprofen and caffeine is in your body. Your general health will also be monitored. The total duration involves a few visits to the clinic, but the exact number and length of these visits will be explained in full detail.

Potential risks and benefits

There are no direct personal health benefits from taking part in this study, as it's not designed to treat any condition you might have. However, your participation helps ensure that new medicines are as effective and safe as existing ones, benefiting future patients. As with any medication, there can be potential side effects from ibuprofen and caffeine, which will be fully explained before you agree to take part. These are generally mild for single doses in healthy individuals, but your safety will be monitored throughout. You are free to withdraw from the study at any time without giving a reason.

Locations (1)

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

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Unverified
Bulgaria

Common questions

What is 'bioequivalence'?

Bioequivalence means that two medicines deliver the same amount of their active ingredients to your body at a similar speed, so they should work in the same way.

Will I be given treatment for a health problem?

No, this study is not designed to treat any health conditions. It's purely to compare how two different medicines behave in healthy people.

What kind of medicines are being tested?

We are comparing two pain relief medicines, both containing 400mg of ibuprofen and 100mg of caffeine.

Is this a new medicine?

It's a comparison of two medicines. One might be a newer version (the 'test' medicine) and the other a commonly used one (the 'reference' medicine).

How long will I need to be involved?

The study involves a few visits to a clinic over a short period, taking one dose of each medicine with a break in between. A full schedule will be provided.