Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Physiologically based pharmacokinetic modelling of oral and intranasal formulations of zolmitriptan in healthy volunteers

This research study, called a Phase I trial, is looking at a medicine called zolmitriptan, which is used to treat migraines. Researchers want to understand exactly how this medicine behaves in the body, comparing two different ways of taking it: as a tablet (oral) and as a nose spray (intranasal). They will do this by giving the medicine to healthy volunteers and then carefully measuring how it's absorbed, how it moves around the body, and how it’s eventually cleared. This type of study helps scientists learn more about new drugs and different ways to deliver them, ensuring they are safe and work effectively for patients with conditions like migraines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Parc De Salut Mar

Enrolment target

Start

03 Jul 2023

healthy

What is this study about?

Imagine you take a medicine for a headache. How does your body actually use it? Does it get into your bloodstream quickly? How long does it stay there? This study aims to answer these very questions for a specific migraine medicine called zolmitriptan.

Researchers are focusing on two common ways people might take this medicine: either by mouth as a tablet or by using a nose spray. They want to see if one way gets the medicine into your system faster, or if your body processes it differently depending on how you take it. This information is really important because it helps doctors understand the best way to give the medicine so it works effectively for patients.

This is a very early stage of research, sometimes called a Phase I study. This means it's about understanding how a medicine works in healthy people, rather than testing if it treats a specific illness. By studying healthy volunteers, scientists can get a clear picture of how the medicine moves through the body without other health problems affecting the results. This knowledge is crucial for developing better and safer treatments in the future.

Key takeaways

This study looks at how a migraine medicine, zolmitriptan, works in healthy bodies.
It compares taking the medicine as a tablet versus a nose spray.
Participation involves clinic visits and blood/urine tests.
It's for healthy adults aged 18 and over.
Your involvement helps improve future medical treatments.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be at least 18 years old – there's no upper age limit, as long as you're in good health.

Both men and women can participate in this research. The most important thing is that you are generally healthy, meaning you don't have any significant ongoing medical conditions that could affect how your body handles the study medicine.

During the screening process, a healthcare professional will ask you some questions and do some checks to make sure this study is right for you and that you meet all the health requirements.

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?
Do you consider yourself generally healthy?
Do you have any ongoing major medical conditions?
Are you comfortable visiting a clinic for multiple appointments?
Are you able to provide blood and urine samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, zolmitriptan, in one of two ways: either as a tablet or as a nose spray. This study involves several visits to a clinic over a set period. During these visits, healthcare professionals will take blood and urine samples to measure how the medicine moves through your body.

You might also have other check-ups like blood pressure readings and heart rate monitoring to ensure your safety. The total duration of your participation in the study, including all visits and follow-ups, would be explained in detail before you agree to join. You would be given a clear schedule of when you need to attend the clinic and what to expect during each visit.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that could help future patients with migraines. You might also receive expert medical checks during your participation. Potential risks could include side effects from the medication, discomfort from blood draws, or slight inconvenience from clinic visits. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is zolmitriptan?

Zolmitriptan is a medicine commonly used to treat migraine headaches.

Why are healthy people needed for this study?

Studying healthy volunteers helps researchers understand how the medicine works in the body without other health problems affecting the results.

Will I be given the medicine for my migraines?

No, this study is not about treating migraines. It's about how the medicine is processed in healthy bodies.

Will I have to stay overnight at a clinic?

The study details about overnight stays will be clearly explained before you agree to participate, as it can vary. Please ask the study team.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without needing to explain why.