Evaluation of the bioequivalence of two products containing esomeprazole under fasting conditions: Esomeprazole-Syrup 40 mg dose (Test) vs. Nexium 40 mg (Comparator). An open, randomized, single dose, four-period, replicate, crossover trial in healthy volunteers
This study is looking at a new liquid version of a medicine called esomeprazole. Esomeprazole is used to treat conditions like heartburn and acid reflux. We want to check if this new liquid medicine works in the same way as an existing, well-known version called Nexium. To do this, healthy adult volunteers will receive both medicines at different times, and we'll take blood samples to see how much of the medicine is absorbed into their bodies. This type of study, called a bioequivalence study, helps ensure that new versions of medicines are just as effective and safe as the original ones. Your participation is important for developing new medications.
At a glance
What is this study about?
This study is called a 'bioequivalence study'. In simple terms, this means we're checking if a new liquid version of a medicine called esomeprazole is handled by your body in the same way as the already approved Nexium tablets. Esomeprazole is a common medicine used to reduce stomach acid, often prescribed for heartburn, indigestion, or other stomach problems.
Even though the medicine (esomeprazole) is already known, it's important to test new ways of taking it – in this case, a liquid syrup. We need to make sure that the liquid form delivers the same amount of medicine to your bloodstream as the existing tablet form. This is crucial because it helps doctors know that when they prescribe the liquid version, it will work just as well as the tablet.
This particular study is being done in healthy volunteers because we're not actually treating any health condition. Instead, we're focusing purely on how the medicine is absorbed and processed by the body. This helps us gather important information without the added complexity of existing health issues affecting the results. Your involvement helps ensure new medicines are safe and effective for patients who need them.
Key takeaways
- This study compares a new liquid esomeprazole with existing Nexium.
- It's for healthy adults aged 18 and over.
- The main goal is to see how your body absorbs the medicines.
- You'll attend clinic visits, take medication, and have blood samples.
- You won't be treated for any medical condition.
- Your participation helps develop new safe medicines.
Who may be eligible?
To take part in this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to participate. Doctors and researchers will check your overall health to make sure you are suitable for the study before you can join.
The main purpose of this study is to measure how your body absorbs the medicines. Therefore, you won't be expected to have any specific health conditions that the medicine usually treats. Instead, the focus will be on your general health and how your body processes the medication.
More detailed health checks will be done by the study team, but generally, if you are a healthy adult, you might be able to take part.
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 over?
- Are you generally in good health?
- Are you comfortable with giving blood samples?
- Are you able to follow specific instructions, like fasting?
- Are you able to attend several scheduled clinic visits?
- Are you not currently taking any medicines that might interfere with the study?
What does participation involve?
If you decide to take part, you'll be one of the healthy volunteers. This study involves several visits to a clinic over a period of time. You'll be given the two different forms of esomeprazole – the new syrup and the existing Nexium – at different times. Each time you take a medicine, you'll need to be in a 'fasting' state, meaning you won't have eaten for a certain number of hours beforehand.
After you take each medicine, the study team will take several blood samples from you over a period of hours. These blood samples will help them measure how much of the medicine is entering your bloodstream and how your body processes it. You'll likely stay at the clinic for extended periods during these measurement days. The study is 'crossover', which means you'll try each medicine, with a break in between, so we can compare them within the same person. The total duration of your involvement will include these study visits and follow-up checks, which will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is esomeprazole and why is it being tested?
Esomeprazole is a medicine that reduces stomach acid, often used for heartburn. This study is testing a new liquid version to ensure it works just as well as the existing tablet form.
Will I be given the medicine to treat an illness?
No, this study is not for treating an illness. It's to see how your body handles the medicine as a healthy volunteer.
Do I have to be a specific age?
Yes, you must be 18 years old or older to take part in this study.
What does 'fasting conditions' mean?
It means you won't be allowed to eat or drink anything (except water) for a certain number of hours before you take the medicine in the study.
Will I have to stay at the clinic?
You will likely need to stay at the clinic for several hours on the days you take the medicine and have blood samples taken.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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