#1 Clinical Trials Search in Europe

A study comparing how midazolam oromucosal solution and midazolam solution for injection are absorbed in healthy volunteers

1 1 1

What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Bkmfrrusqdwe Ixiqplxqyruv E Dqyjeebnajzhhea En Srwrh Lawo Porto Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not recruiting
10.07.2023

Trial locations

Investigated drugs:

Midazolam administered as an oromucosal solution is a medication that is applied to the lining of the mouth to help produce a calming or sedative effect.

Midazolam administered as an injection is a medication given through a needle into the muscle to produce a calming or sedative effect.

No disease is specified in the provided source data.

Trial ID:
2023-504903-10-00
Protocol code:
LESVIBUCCO/23/BQ-3
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

Other Trials to Consider

  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary Poland Portugal +1