Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, Portugal
Not recruiting
A study comparing how midazolam oromucosal solution and midazolam solution for injection are absorbed in healthy volunteers
Verified siteRegistered drug
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This study aims to compare how the body absorbs and processes two different versions of the medication midazolam. This drug is typically used to produce a calming or sedative effect. One version being studied is Buccolam, which is an oromucosal solution, a liquid medicine that is held in the mouth against the cheek lining to be absorbed. The other version is Hypnovel, which is a solution for injection administered through an intramuscular injection, meaning the medicine is delivered directly into a muscle.
The research focuses on bioavailability, which describes the amount of a drug that enters the bloodstream and how quickly it gets there. Participants will undergo a process where they receive one of the treatments after fasting, meaning they will not eat for a certain period before the dose. After a period of time, they will receive the other treatment. This approach allows for a direct comparison of how each method of taking the medication affects the body's levels of the drug and its metabolites, which are the substances created when the body breaks down the medication.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- You must provide written informed consent, which means you sign a document agreeing to take part in the study after the researchers explain everything to you.
- You must be a non-smoker or an ex-smoker, meaning you have not used tobacco or nicotine products for at least 3 months.
- You must be willing to follow all the rules and steps required by the study.
- Women must either not be able to have children or agree to use an effective form of contraception (a method used to prevent pregnancy) starting 4 weeks before the study begins and continuing until the end.
- You must be at least 18 years old when you sign the consent form.
- Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be between 18.5 and 35.0, and you must weigh at least 50 kg.
- You must have no significant history of medical conditions (health problems).
- A physical exam must show no significant health issues.
- Your vital signs, which include measurements like blood pressure, heart rate, and temperature, must be within normal ranges.
- An ECG (Electrocardiogram), which is a test that records the electrical activity of your heart, must show no abnormalities.
- Your laboratory tests, such as blood or urine tests, must show no significant health issues.
- You must test negative for HIV (a virus that affects the immune system), Hepatitis B, and Hepatitis C (viruses that affect the liver).
Who cannot join the trial?
30 criteria
- You have a known allergy or hypersensitivity, which is an extreme immune system reaction, to the study medicine or any of its excipients, which are the inactive ingredients used to make the medicine.
- You have physical issues with your airway, such as a difficult airway, or naturally enlarged mouth, tongue, or a mandibular dysplasia, which is an abnormality in the development of the lower jaw.
- You have a history of using alcohol or drugs in an abusive manner.
- Your blood tests show serum transaminases (specifically ALT or AST), which are enzymes that indicate liver health, are higher than the normal limit.
- Your creatinine clearance, a measurement used to check how well your kidneys (the organs that filter your blood) are working, is below the normal range.
- You test positive for drugs of abuse or ethanol (alcohol) during testing.
- You have used a depot injection (a long-acting medication released slowly into the body) or a drug implant within the last 6 months, except for birth control.
- You have consumed more than 14 units of alcohol per week if male, or 7 units if female, over the last 6 months.
- You consume more than 500 mg of methylxanthines daily, which are substances found in products like coffee, tea, chocolate, and certain sodas.
- You participated in a clinical trial within the last 2 months.
- You participated in more than 2 clinical trials within the last 12 months.
- You have a known history of severe hypersensitivity (extreme allergic reactions) to any other medication.
- You have donated blood, experienced significant blood loss of 450 mL or more, or had plasmapheresis (a process that separates the liquid part of blood from the cells) in the last 2 months.
- You have difficulty with fasting (not eating for a period of time) or follow a special diet, such as vegan, lactose intolerant, low-fat, or low-sodium diets, that might interfere with the study meals.
- Your veins are not suitable for intravenous puncture, which is the process of inserting a needle into a vein to give medicine.
- If you are a woman, you have a positive pregnancy test in your blood or urine.
- If you are a woman, you are currently breast-feeding.
- You have used any prescription drugs, over-the-counter medicines, vitamins, or herbal supplements (such as St John’s Wort) within the 2 weeks before the study, unless the doctor says it is safe.
- You have used CYP3A4 or CYP3A5 inhibitors (medicines that slow down how your body processes certain drugs) or inducers (medicines that speed up how your body processes certain drugs) within the last 4 weeks.
- You have eaten pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit products within the last week.
- You have a medical condition affecting your gastrointestinal (stomach and intestines), renal (kidneys), or hepatic (liver) systems, such as a peptic ulcer, inflammatory bowel disease, or pancreatitis.
- You have had surgeries such as a cholecystectomy (removal of the gallbladder) or gastrectomy (removal of part of the stomach).
- Any condition you have that might affect pharmacokinetics, which is how your body absorbs, moves, breaks down, and gets rid of the medicine.
- You have a history of cardiovascular (heart and blood vessel) disease or respiratory (lung) disease.
- You have a history of renal (kidney) or hepatic (liver) impairment, which means these organs are not functioning perfectly.
- You have a history of severe respiratory insufficiency, which means your lungs cannot get enough oxygen into your blood.
- You have a history of sleep apnea syndrome, a condition where breathing repeatedly stops and starts during sleep.
- You have a history of myasthenia gravis, a disease that causes weakness in the muscles.
- You have a current or recurring problem in your oral cavity (mouth) or mucosa (the moist lining of the mouth).
- Any other health condition that the investigator decides makes you unsuitable for the study.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
What is already known about the treatment
Midazolam
This medication is a sedative that is commonly used to help people relax or fall asleep before medical procedures. It is administered as a liquid applied directly to the lining of the mouth to allow it to be absorbed quickly into the bloodstream. As a benzodiazepine, it works by increasing the effects of a natural chemical in the brain that helps calm the nervous system. This substance is well-established in medical practice for treating anxiety and inducing sleep.
Midazolam
This medication belongs to a group of drugs called benzodiazepines and is used to calm patients and induce sedation. It is administered as a liquid through an injection into a muscle, allowing the medicine to enter the body steadily. On a molecular level, it works by enhancing the activity of specific receptors in the brain that reduce nerve cell excitability. This drug is widely recognized and used in clinical settings to manage anxiety and facilitate medical treatments.
Investigated diseases
No disease is specified in the provided source data.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504903-10-00Protocol codeLESVIBUCCO/23/BQ-3Estimated enrolment24 patientsSponsorNeuraxpharm Pharmaceuticals S.L.
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?