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Comparative Bioavailability of Midazolam 7.5 mg/1.5 mL Oromucosal Solution (Buccolam®) Versus 10 mg/2 mL Solution for Injection (Hypnovel®) in Healthy Subjects.
EU CTIS ID: 2023-504903-10-00
What this study is testing
To investigate the pharmacokinetics of a single dose of midazolam oromucosal solution (Buccolam®) compared to midazolam solution for intramuscular injection (Hypnovel®) in healthy volunteers under fasting conditions.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Free written informed consent prior to any procedure required by the study.
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first study period until the end of study.
- Male or female subject ≥18 years at the time of signing the informed consent.
- Body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive, and body weight ≥50 kg.
You likely can't join if
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- Difficult airway, congenital mouth and tongue enlargement, and mandibular dysplasia.
- History of alcohol or drug abuse.
- Serum transaminases ALT or AST above the upper limit of the normal range.
- Estimated renal creatinine clearance (CLCR) below the lower limit of normal range (i.e., 90-120 mL/min/1.73 m2 for males and 80-110 mL/min/1.73 m2 for females) for subjects with age up to 59 years, or below 80 mL/min/1.73 m2 for males and below 70 mL/min/1.73 m2 for females with age of 60 years or above, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
- Positive result in drugs-of-abuse or ethanol tests.
See the full eligibility criteria
Who can join
- Free written informed consent prior to any procedure required by the study.
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first study period until the end of study.
- Male or female subject ≥18 years at the time of signing the informed consent.
- Body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive, and body weight ≥50 kg.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on vital signs.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
What rules you out
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- Difficult airway, congenital mouth and tongue enlargement, and mandibular dysplasia.
- History of alcohol or drug abuse.
- Serum transaminases ALT or AST above the upper limit of the normal range.
- Estimated renal creatinine clearance (CLCR) below the lower limit of normal range (i.e., 90-120 mL/min/1.73 m2 for males and 80-110 mL/min/1.73 m2 for females) for subjects with age up to 59 years, or below 80 mL/min/1.73 m2 for males and below 70 mL/min/1.73 m2 for females with age of 60 years or above, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Known severe hypersensitivity reaction to any other drug.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- If woman, positive pregnancy test in serum.
- If woman, she is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of prescription or nonprescription medicinal products, vitamins, food supplements or herbal supplements (including St John’s Wort) within the previous 2 weeks prior to admission to Period 1 or during the washout period prior to Period 2, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Use of CYP3A4 or CYP3A5-inhibitor (antiproteases, ketoconazole, itraconazole, erythromycin and clarithromycin) or inducer drugs (e.g., rifampicin, phenobarbital, carbamazepine) within the previous 4 weeks prior to admission to Period 1 or during the washout period prior to Period 2.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- Positive result in drugs-of-abuse or ethanol tests.
- If woman, positive pregnancy test in urine.
- Any other condition that the investigator considers to render the subject unsuitable for the study period.
- History of cardiovascular or respiratory disease.
- History of renal or hepatic impairment.
- History of severe respiratory insufficiency.
- History of sleep apnea syndrome.
- History of myasthenia gravis.
- Current or recurrent abnormality in the oral cavity/mucosa.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.