Pharmacokinetic Modeling of Oral and Intranasal Zolmitriptan in Healthy Volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study examines the medication zolmitriptan, which is used to treat migraine attacks. Two ways of giving the drug are compared: a small tablet that is taken by mouth (oral) and a spray that is placed into the nose (nasal spray). The participants are healthy adults who do not have any known illnesses, allowing the researchers to focus on how the drug behaves in the body without the influence of disease.
The purpose of the study is to compare how the drug is absorbed and works when taken by mouth versus a nasal spray. Volunteers will receive each form of the medication on separate occasions. After each dose, small amounts of blood will be taken at several time points over the next 24 hours, and basic health checks such as heart rate and blood pressure will be recorded at the same intervals. The study does not involve any experimental treatments beyond the two forms of the medication.
Key concepts include pharmacokinetic analysis, which looks at how quickly the drug appears in the blood (the liquid part of blood called plasma) and how long it stays there. Measurements of heart rate (the number of beats per minute) and blood pressure (the force of blood against artery walls) help assess the drug’s immediate effects on the cardiovascular system. The information gathered will help determine which method provides faster relief and a safer profile for people who need migraine treatment.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- Be a healthy adult, male or female.
- Be at least 18 years old and not older than 55 years.
- Have a Body mass index (BMI) between 18 and 30; BMI is a simple calculation that compares your weight to your height.
- Be a non‑smoker (do not regularly use cigarettes or other tobacco products).
- Agree to follow the study’s rules about what you can eat, how you can exercise, and how much alcohol you may drink, even when you are not staying at the study center.
- Be able to read and understand Spanish and follow the study instructions.
- Not be under any kind of legal or administrative supervision (for example, not on probation or similar).
- Sign an informed consent form before any study procedures are done, showing that you understand and agree to take part.
Who cannot join the trial?
18 criteria
- Lifetime substance use disorders (SUD) – a long‑term pattern of using drugs or alcohol that causes problems, as defined in the medical manual DSM‑5.
- Participated in another investigational clinical study within 3 months before receiving the study medication.
- Positive blood or urine test for illegal drugs or a positive breath test for alcohol before receiving the study medication.
- History of anxiety or depression that has not fully recovered within the past 12 months (these are mood‑related conditions that affect mental health).
- Any other significant disease or condition that the doctor believes could interfere with study procedures, affect the results, or put the participant’s safety at risk.
- Ongoing gastrointestinal diseases or past gastrointestinal surgery that could affect how the drug is absorbed (problems with the stomach or intestines).
- Important abnormal findings in the physical exam, vital signs, ECG (heart tracing), or laboratory tests, according to the investigator.
- Clinically relevant abnormalities in a 12‑lead ECG, such as conduction pathway disorders (problems with the heart’s electrical system).
- Positive test for Hepatitis B, Hepatitis C, or HIV antibodies (these are infections of the liver or immune system).
- Known hypersensitivity (allergy) to any drug or to any inactive ingredient in the study medication.
- Use of medicines that induce or inhibit liver drug metabolism within one month before or during the study, or consumption of citrus juice during the study (these drugs can change how the liver processes other medicines).
- Use of monoamine oxidase A (MAO‑A) or monoamine oxidase B (MAO‑B) inhibitors within one month before or during the study (these are medicines that affect certain brain chemicals).
- Use of ergot‑containing drugs or 5‑HT1B/1D agonists (e.g., dihydroergotamine, methysergide) within 24 hours of using the study nasal spray (these are specific migraine medicines).
- Any prescription or over‑the‑counter product, including herbal, homeopathic, vitamins, minerals, or nutritional supplements, taken within 2 weeks before the study drug, except oral contraceptives.
- Consumption of foods or beverages containing xanthine (more than 5 cups of coffee, tea, or cola drinks per day; xanthine is a stimulant found in these drinks).
- Donation of blood or plasma within 1 month before the study drug, receiving a blood or plasma transfusion, or planning to donate blood or plasma within 1 month after the study drug.
- History of inadequate venous access or difficulty donating blood (problems with finding a suitable vein).
- Inability or unwillingness to follow restrictions on diet, physical exercise, alcohol, and xanthine‑containing items when not staying at the clinical unit.
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Investigated drugs
This is a small tablet that you place in your mouth, where it quickly breaks apart and dissolves without needing water. It contains the migraine‑relief medicine zolmitriptan. In the study it is used as the standard or “comparator” product, meaning it represents the usual oral way the drug is taken. Researchers look at how this tablet is absorbed into the blood and how it affects heart rate and blood pressure, and then compare those results with the other form being tested. Zomig nasal spray
This is a spray that is applied into the nose. It also contains zolmitriptan, but instead of swallowing a tablet, the medicine is absorbed through the lining of the nose. In the trial it is the “test” product, so the study examines whether this intranasal route delivers the drug faster or more effectively than the oral tablet. The spray’s impact on blood levels of the drug, heart rate, and blood pressure is measured and compared with the oral tablet results.
What is already known about the treatment
Zolmitriptán Normon 5 mg comprimidos bucodispersables EFG.
It is taken by mouth as a tablet that dissolves in the mouth without water. Zolmitriptan is an approved medication that is widely used to treat acute migraine attacks. It works by stimulating certain serotonin receptors, which narrows blood vessels in the brain and eases headache pain. The drug belongs to the triptan class, known as serotonin 5‑HT1B/1D receptor agonists.
Zomig 5 mg solución para pulverización nasal
It is administered as a nasal spray that delivers the medicine directly into the nose. Zomig is an approved product used for the rapid relief of migraine symptoms. It acts by activating serotonin receptors, causing blood vessels around the brain to tighten and reducing the migraine. This medication is also classified as a triptan, a type of serotonin receptor agonist.
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
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