Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Randomised, crossover bioavailability clinical trial of oral minoxidil 1 mg, after single and multiple dose administration to healthy volunteers under fasting conditions

This research study is investigating an oral (taken by mouth) 1mg dose of minoxidil in healthy women. Minoxidil is a medication commonly used for hair loss, specifically for a type called androgenetic alopecia. The main goal is to understand how the body absorbs, distributes, uses, and gets rid of this medicine. Researchers will study this after you take a single dose and also after you've taken it several times over a short period. Participants will be asked to fast before taking the medication. This is an early-stage study, meaning it's one of the first times this specific formulation and dose is being looked at in healthy people, to gather important information about how it works before it can be studied in larger groups.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Industrial Farmaceutica Cantabria S.A.

Enrolment target

Start

20 Oct 2023

Androgenetic alopecia

What is this study about?

This research is a 'bioavailability' study, which means scientists are trying to learn how much of the minoxidil medicine gets into your bloodstream and how quickly. They'll be using a 1mg tablet of minoxidil, a medicine specifically used to treat hair loss, particularly a common type called androgenetic alopecia.

Think of it like this: when you take a tablet, your body has to break it down and absorb it. This study wants to measure exactly how much of the minoxidil is absorbed and how consistently this happens. They'll be looking at this after you take just one tablet, and again after you've taken tablets over a few days. Knowing this helps them understand if the medicine reaches the right levels in your body to be effective and safe.

The study is being carried out in healthy volunteers, rather than people with hair loss. This is common practice in early-stage trials. By studying healthy individuals, researchers can focus purely on how the body handles the drug without other health conditions making the results harder to understand. The information gathered here is crucial for deciding how the medicine might be used in the future for people experiencing hair loss.

Key takeaways

This study looks at how a 1mg minoxidil tablet works in healthy women.
It's an early-stage study to understand how the medicine is absorbed.
Participation involves taking the medicine, fasting, and having regular checks.
The study helps gather important information for future use of minoxidil.
You won't be treated for hair loss; you are helping medical research.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy women aged 18 years and older. There isn't an upper age limit mentioned, so if you're a woman over 18, you might be suitable for this research.

Being 'healthy' for a study usually means you don't have any major medical conditions that could affect how the medicine works or make your participation unsafe. This includes things like heart problems, kidney or liver issues, or other significant illnesses.

Before you can join, the research team will do medical checks to make sure this study is safe and appropriate for you. They will explain all the specific health requirements in detail.

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 a woman?
Are you aged 18 years or older?
Are you generally in good health?
Are you able to follow study instructions, including fasting?

Answer every question to see your result.

What does participation involve?

If you take part, you'll be involved in a 'crossover' study. This usually means you'll have different study periods where you receive the medication, followed by 'washout' periods where you don't take any study medicine. You might receive the medicine in one way then swap to another in a later period.

You'll likely need to spend some time at the clinic, potentially for several days or overnight stays, for each study period. During these times, you'll receive the oral minoxidil 1mg dose. You'll be asked to fast (not eat) before taking the medicine, and meals will be controlled afterwards. Nurses and doctors will take regular blood samples to measure how the minoxidil is working in your body. Your heart rate, blood pressure, and other vital signs will also be checked frequently.

There will also be follow-up visits or calls after each study period to ensure you are well. The total duration of your participation, including all visits and washout periods, will be explained fully by the study team.

Potential risks and benefits

Potential benefits of taking part include contributing to medical knowledge that could help future patients with hair loss. You will also receive careful medical monitoring throughout the study. However, there's no guarantee that participating will directly benefit your health. Potential risks might include common side effects associated with minoxidil, such as headaches, dizziness, or changes in blood pressure, though these would be closely monitored. There might also be discomfort from blood draws. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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 minoxidil?

Minoxidil is a medication often used to help with hair loss by encouraging hair growth.

Why are you studying healthy women?

Studying healthy volunteers helps researchers understand how the body handles the medicine without other health issues complicating the results.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or sometimes even drink certain liquids for a set time before taking the medicine.

Will I get free treatment for hair loss if I join?

No, this study is not designed to treat hair loss; it's to gather information about how the medication works in the body.

What is a 'crossover' study?

It means you might receive the study medicine in different ways over different periods, followed by time off the medicine.