RANDOMISED, CROSSOVER BIOEQUIVALENCE CLINICAL TRIAL OF MONTELUKAST 10 MG CAPSULES VS MONTELUKAST 10 MG FILM-COATED TABLETS, AFTER A SINGLE ORAL DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS UNDER FASTING CONDITIONS.
This study is looking at an asthma medicine called montelukast. It’s a specific type of study known as a 'bioequivalence' trial. This means we're comparing two different forms of the same medicine: a 10 mg capsule and a 10 mg film-coated tablet. The main goal is to check if these two forms deliver the medicine into the body in the same way, and at similar amounts and speeds, when given once by mouth to healthy adult volunteers who haven't eaten recently. This helps ensure that switching between the two forms would have the same effect. We're interested in how much medicine gets into the bloodstream and how quickly it reaches its highest level.
At a glance
What is this study about?
This research study is about a medicine called montelukast, which is often used to treat asthma. The main purpose of this study is to compare two different versions of montelukast: a 10 mg capsule and a 10 mg film-coated tablet. We want to see if your body processes these two forms of the medicine in exactly the same way. Think of it like comparing two brands of crisps – they might look a bit different, but do they taste exactly the same? In this case, we’re checking if they deliver the same amount of medicine at the same speed.
This type of study is called a 'bioequivalence' study. It's really important because if two different forms of a medicine are 'bioequivalent', it means they can be used interchangeably, and doctors can be confident that patients will get the same treatment effect regardless of which type they take. This study involves giving a single dose of each medicine to healthy volunteers who haven't eaten anything beforehand. This helps us get a clear picture of how the body handles the medicine without food interfering.
By carefully measuring how quickly the medicine gets into the bloodstream and how much of it is there over time, we can decide if the capsule and the tablet work in the same way. This helps make sure that medicines available to patients are consistent and reliable, no matter which version they receive from their pharmacy.
Key takeaways
- This study compares a montelukast capsule and tablet to see if they work the same.
- It's for healthy adult volunteers, aged 18 and over.
- You'll take each medicine on separate occasions, after not eating.
- The goal is to ensure different medicine forms are equally effective for asthma.
- Participation involves clinic visits and blood tests.
Who may be eligible?
This study is looking for healthy volunteers. To be able to take part, you need to be at least 18 years old. There is no upper age limit, so adults of any age can potentially join.
Both men and women are welcome to participate in this study. The researchers want to include a diverse group of people to make sure the results are as widely applicable as possible.
Because this is a study looking at how the body handles the medicine, you will need to be in good overall health. The research team will do some checks to make sure you are healthy enough to take part safely.
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 able to visit a clinic for several hours on study days?
- Are you comfortable with giving blood samples?
- Are you able to follow specific instructions, like fasting?
What does participation involve?
If you decide to take part in this study, you will visit the research clinic on a few occasions. On study days, you will be given a single dose of either the montelukast capsule or the montelukast tablet by mouth. You will then have several blood samples taken over a set period of time to measure how much montelukast is in your body. This will be done after you haven't eaten for a while (fasting).
Since this is a 'crossover' study, at a later visit, you will receive the *other* form of the medicine (if you had the capsule first, you'll get the tablet second, and vice-versa), and the same blood sampling process will be repeated. There will be a 'washout' period between these two medicine-taking occasions, meaning a break to ensure the first dose has left your system completely before you take the second.
Each visit will involve these assessments over several hours. The total duration of your participation, including the breaks between taking the different medicines, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means we're checking if two versions of the same medicine work in exactly the same way in your body.
Why is this study only for healthy people?
By studying healthy people, we can clearly see how the medicine works on its own, without other health conditions making things complicated.
Will I get both the capsule and the tablet?
Yes, you will try both forms of the medicine, but at different times, with a break in between.
What is 'fasting conditions'?
It means you won't eat anything for a certain period before taking the medicine, usually overnight.
Will I get paid for taking part?
Details about any compensation or reimbursement for travel and time will be explained by the study team.
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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