Evaluation of the bioavailability of two products containing esomeprazole under fasting and fed conditions: Esomeprazole-Syrup 40 mg dose (Test) vs. Nexium 40 mg (Comparator). A monocentric, open, randomized, single dose, four-period, crossover trial in healthy volunteers
This research is looking at two types of esomeprazole, a medicine often used for stomach acid problems. One is a new liquid version (esomeprazole syrup), and the other is the standard pill (Nexium). The main goal is to find out how much of the medicine the body takes in, and how quickly, when people take it with or without food. This is important to make sure the new liquid medicine works as expected. The study involves healthy people and is a very early stage of testing. It's about understanding how the medicine behaves in the body, rather than treating any illness.
At a glance
What is this study about?
Imagine you have a new type of drink that's meant to help with a headache, and you want to know if it works just as well as the headache pill you usually take. This study is a bit like that, but for a medicine called esomeprazole, which is used for stomach problems like heartburn or acid reflux.
Researchers are comparing a new liquid form of esomeprazole (a syrup) with the common pill form (called Nexium). They want to see how well and how quickly the body absorbs the medicine from both forms. This is really important because if the body doesn't absorb enough medicine, it won't work properly. They are also checking if eating food changes how the medicine is absorbed, as this can sometimes affect how medicines work.
This study is a very early step in checking new medicines. It’s not about treating an illness, but about understanding how the medicine behaves inside healthy people. This helps scientists decide if the new liquid form is a good option to develop further for patients who might find it easier to take than a pill, such as children or people who struggle to swallow tablets.
Key takeaways
- Compares a new liquid esomeprazole with an existing pill form.
- Aims to understand how the body absorbs the medicine.
- Checks absorption when taken with and without food.
- Involves healthy adult volunteers, aged 18 and over.
- This is an early-stage study, not a treatment trial.
Who may be eligible?
To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so older adults can also be included.
Both men and women are welcome to take part in this study. The researchers aim to have a mix of participants to get a good understanding of how the medicine works across different people.
Because this is an early study to understand how the medicine behaves in the body, participants must be healthy. This means you shouldn't have any significant ongoing health problems or be taking a lot of other medications that might interfere with the study. The study team will check your health carefully to make sure it's safe 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 in good health?
- Are you comfortable with regular blood tests?
- Are you able to visit a study centre multiple times?
- Are you able to follow specific instructions about eating and taking medication?
What does participation involve?
If you decide to take part, you would visit a single study centre several times. The study will involve giving you either the new esomeprazole syrup or the standard Nexium pill. You will take the medicine on an empty stomach some times, and after eating food on other occasions. This is to see how food affects the absorption. There will be breaks between each time you take the medicine to make sure the first dose has completely left your body before the next part of the study begins. During your visits, you'll have blood samples taken regularly after you've taken the medicine, so the researchers can measure how much of it is in your bloodstream over time. You would also have general health checks. The total duration of your involvement, including all visits and breaks, will be explained fully by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is esomeprazole?
Esomeprazole is a medicine commonly used to reduce stomach acid, often prescribed for conditions like heartburn or acid reflux.
Why is this study using healthy volunteers?
This is an early-stage study to understand how the body absorbs the medicine, so it's done in healthy people first to clearly see its effects without other health conditions or medicines complicating the results.
What does 'fasting and fed conditions' mean?
It means you'll take the medicine sometimes when you haven't eaten for a while (fasting) and other times shortly after you've had a meal (fed), to see if food makes a difference.
Will I receive treatment for an illness?
No, this study is not designed to treat any illness. It's purely to understand how the medicine is absorbed in healthy people.
What does a 'crossover trial' mean?
It means you will receive both the new syrup and the standard pill at different times during the study, allowing researchers to compare them directly within the same person.
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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