Single Dose Crossover Comparative Bioavailability and Food Effect Study of Celecoxib 10 mg/1 mL Oral Suspension versus Celebrex®️ (celecoxib) 200 mg Capsules Following the Administration of a 200 mg Dose in Healthy Adult Volunteers / Fasting and Fed State.
This study is looking at a new liquid form of a medicine called celecoxib, which is used to treat pain, for example, from muscle and joint conditions or painful periods. The main goal is to see how much of the new liquid medicine gets into the body and how quickly, compared to the celecoxib capsules that are already available (known as Celebrex®). We'll test this both when people have eaten and when they haven't, to check if food makes a difference. This type of study helps make sure any new medicine works just as well and is absorbed similarly to existing ones. It's an early-stage study to understand the medicine better.
At a glance
What is this study about?
Imagine you take a medicine in a capsule, but sometimes a liquid version would be easier – for instance, if you find swallowing capsules difficult. This study is testing a new liquid form of a pain relief medicine called celecoxib. Celecoxib is commonly used for conditions that cause pain, such as problems with your muscles or joints, or for period pain.
The main aim of this study is to compare this new liquid celecoxib with the celecoxib capsules (known as Celebrex®) that are already widely used. We want to find out if your body absorbs the liquid medicine in a similar way to the capsules. This means checking how much of the medicine gets into your bloodstream and how quickly, as this affects how well it works. We'll also look at whether eating food before taking the medicine changes how your body absorbs it.
Studies like this are an important step in developing new medicines. By understanding how the liquid form behaves in the body compared to the capsule, scientists can make sure that if the liquid medicine becomes available, it will be just as effective and safe for patients. This is a very early stage study, focusing on understanding how the medicine works in the body rather than testing if it treats a specific illness.
Key takeaways
- Tests a new liquid form of celecoxib (pain medicine).
- Compares it to the standard celecoxib capsules.
- Checks how the body absorbs the medicine, with and without food.
- Aims to ensure the liquid form is absorbed similarly to the capsules.
- For healthy adult volunteers, 18 years and older.
Who may be eligible?
This study is looking for healthy adult volunteers. If you are 18 years old or older, you might be able to take part. There is no upper age limit for joining.
Both men and women are welcome to participate in this study. The researchers want to include a diverse group of people to get a good understanding of how the medicine works.
As this is for healthy volunteers, you would typically need to be in good general health, without any major ongoing medical conditions or taking regular medications that could interfere with the study medicine. Specific health checks would be done by the study team to confirm suitability.
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 willing to follow specific dietary instructions?
- Can you commit to multiple study visits and blood tests?
What does participation involve?
If you decide to take part, you would receive doses of both the new liquid celecoxib and the standard celecoxib capsules at different times, so the researchers can compare them. This is called a 'crossover' design. You would have a number of visits to the study clinic, and on some of these visits, you might need to stay for a while after taking the medicine so blood samples can be collected. These samples help measure how much of the medicine is in your body.
You would be given specific instructions about food and drink, as the study will test the medicine both after fasting (not eating for a certain period) and after a meal. You would be carefully monitored by medical staff throughout the study. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail before you agree to join.
Potential risks and benefits
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Common questions
What is celecoxib used for?
Celecoxib is a medicine used to help with pain, for conditions like painful joints, muscles, or period pain.
What does 'bioavailability' mean?
It means how much of the medicine actually gets into your body and becomes available to work.
Why test with and without food?
Food can sometimes affect how quickly or how much of a medicine your body absorbs, so it's important to check this.
Is this a new medicine not available yet?
Celecoxib capsules are available. This study is testing a new liquid version of the same medicine to see how it compares.
Will I get paid for taking part?
Many studies offer payment or cover expenses for your time and travel. This would be explained before you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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