Evaluation of bioequivalence of two products containing 600 mg ibuprofen: Ibuprofen Sopharma 600 mg film-coated tablets (Test) vs. Brufen 600 mg film-coated tablets (Comparator). A monocentric, open, randomized, single dose, two-period, crossover trial in healthy volunteers
This study, called a bioequivalence trial, aimed to compare two different ibuprofen tablets, both containing 600 mg of the painkiller. One was called Ibuprofen Sopharma 600 mg and the other was Brufen 600 mg. Researchers wanted to make sure that the body absorbs the active ingredient from both tablets in a similar way and at a similar speed. They did this by giving healthy adult volunteers a single dose of each tablet on separate occasions. This type of study helps ensure that different versions of a medicine are equally effective, even though they might be made by different companies.
At a glance
What is this study about?
Imagine you have two different brands of ibuprofen, both saying they contain 600mg. You'd expect them to work the same, right? This study is designed to check just that. It's not about finding new uses for ibuprofen or testing it on people who are unwell; instead, it's a very specific kind of study that compares two existing ibuprofen tablets.
The main goal is to see if your body processes and absorbs the ibuprofen from both tablets in a very similar way. This is important because even if two tablets have the same amount of medicine, the way they are made can affect how quickly and how much of the medicine gets into your bloodstream. If they are 'bioequivalent,' it means they are considered interchangeable and should have the same effect.
So, this research helps ensure that when doctors prescribe a generic version of a well-known medicine, it will work just as effectively as the original. It's a crucial step in making sure medicines are reliable and consistent for everyone.
Key takeaways
- This study compares two ibuprofen tablets to ensure they work similarly.
- It involves healthy adult volunteers, not patients with an illness.
- Participants take single doses of each tablet on different occasions.
- Blood samples will be taken to measure how the body absorbs the medicine.
- The goal is to confirm that generic ibuprofen is just as effective as the original.
- Participation involves multiple visits to one study site.
Who may be eligible?
This study is looking for healthy adults. You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, so older adults could also be considered.
Crucially, you must be in good overall health. This means you should not have any ongoing illnesses or medical conditions that could affect how your body handles medication or make it unsafe for you to take part. The study will likely involve medical checks to confirm your health.
Both men and women are welcome to participate. The study doesn't mention any specific exclusions based on gender, but you would be screened to ensure you meet all other health criteria.
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 with no significant ongoing medical conditions?
- Are you able to attend appointments at a single study location?
- Are you comfortable with having regular blood samples taken?
- Are you available for participation over a period of a few weeks?
What does participation involve?
If you decide to take part, you'll be part of a single-centre study, meaning all your visits will be at one location. You'll participate in two different periods. During each period, you'll be given a single dose of one of the ibuprofen tablets (either Ibuprofen Sopharma or Brufen).
Because it's a 'crossover' study, you won't know which tablet you're getting first, but you will receive both tablets over the course of the study, just at different times. There will be a 'washout' period between these two times – this is a break to make sure the first dose of medicine has completely left your body before you take the second.
Throughout the study days, you'll have blood samples taken regularly to measure how much ibuprofen is in your system. This helps the researchers understand how your body absorbs and processes the medication. The total duration of your involvement will include these two dosing periods and the washout time in between, which typically might span a few weeks.
Potential risks and benefits
Locations (1)
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Common questions
What is the main purpose of this study?
The main purpose is to compare two different ibuprofen tablets to see if they are absorbed into the body in the same way, ensuring they are equally effective.
Will I be given ibuprofen for an illness?
No, this study is for healthy volunteers and is not testing ibuprofen to treat any illness. You will take it as part of the research.
What does being 'healthy' mean for this study?
It means you generally feel well and don't have any ongoing medical conditions that could interfere with how your body processes medication or make it unsafe for you to participate.
Will I know which ibuprofen tablet I'm taking?
You will take both tablets during the study, but you won't know which one you're taking at each specific time. This is standard practice in these types of trials.
How long will my involvement in the study last?
The overall duration for your participation will involve two separate dosing periods with a break in between, typically spanning a few weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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