Comparative Bioavailability of Midazolam 7.5 mg/1.5 mL Oromucosal Solution (Buccolam®) Versus Midazolam 10 mg/2 mL Solution for Injection (Hypnovel®): A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting Conditions.
This study is looking at two forms of a medicine called midazolam. One is a liquid given into the mouth (Buccolam), and the other is an injection (Hypnovel). We want to find out how much of the medicine gets into the body and how quickly, to see if they are similar. This is being done in healthy adult volunteers who haven't eaten for a while before taking the medicine. It's a single and simple study where participants will try each medicine in turn with a break in between. Understanding how the body uses these medicines helps doctors choose the best way to give them, ensuring they work effectively and safely for patients who need them.
At a glance
What is this study about?
Imagine you have a headache and take a painkiller. You want to know if it will work and how quickly. This study is similar, but for a medicine called midazolam. Midazolam can be used for different reasons, like helping someone relax before a medical procedure or to treat seizures, especially in children.
In this study, we're comparing two specific ways of giving midazolam: one is a liquid that's given by mouth (called Buccolam), and the other is an injection (called Hypnovel). Both deliver the same active medicine, but we need to understand if your body takes them in in the same way. This helps doctors know which option might be best for different patients.
We're focusing on how much of the medicine gets into your bloodstream and how fast it gets there. This helps us understand if giving it by mouth is as effective as giving it by injection in terms of how your body uses it. This kind of research is important because it ensures medicines are given in the safest and most effective way possible, making sure patients get the right amount of medicine at the right time.
Key takeaways
- This study compares a liquid mouth medicine of midazolam with an injected version.
- It aims to see if both methods deliver the medicine similarly to your body.
- The study is for healthy adults, aged 18 or over.
- Participants will try each medicine in turn, with blood tests to check how it's used by the body.
- Your participation helps improve how medicines are given to patients in the future.
Who may be eligible?
To join this study, participants must be healthy adults. This means you shouldn't have any major ongoing health problems or illnesses that would affect how your body handles medicines.
Both men and women are welcome to take part in this research study, and you must be at least 18 years old. There is no upper age limit, as long as you are generally healthy.
Because we want to see how the medicines work in healthy people, you'll have some basic health checks, like blood tests, to make sure you're suitable to join.
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 healthy with no major ongoing medical conditions?
- Are you able to follow study instructions, including fasting when required?
- Are you comfortable with having blood samples taken several times?
What does participation involve?
If you decide to take part in this study, you'll visit the clinic a few times. Before each time you take the medicine, you'll need to fast, which means not eating anything for a certain period, usually overnight. On each dosing day, you will receive one of the midazolam medicines – either the mouth liquid or the injection – and then blood samples will be taken regularly over several hours. This helps us track how the medicine moves through your body.
There will be a break between the two times you take the medicine to make sure the first dose has completely left your system. You'll switch treatments, meaning if you had the mouth liquid first, you'll have the injection next, and vice-versa. Throughout the study, medical staff will check on you to make sure you're feeling well and to record any side effects. The total time you'll be involved in the study, including all visits and follow-ups, will be explained fully before you decide to take part.
Potential risks and benefits
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Common questions
What is midazolam used for?
Midazolam is a medicine used to help people relax, reduce anxiety, or treat seizures.
Why are you studying two different ways of giving the same medicine?
We want to see if giving midazolam by mouth works as well as giving it by injection, by checking how the body takes it in. This can help doctors choose the best option for patients.
Will I get paid to participate?
Information about payment or reimbursement for your time and travel will be provided by the study team.
Do I need to be ill to join this study?
No, this study is actually for healthy adults. We want to see how the medicine works in people without other health issues.
How long will I be involved in the study?
The study involves a few visits over a period, and the full duration will be explained by the study team before you sign up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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