Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Pharmacokinetics of Nicorandil 40 mg Extended-Release Capsules in Healthy Subjects Under Fasting and Fed Conditions.

This research is a 'Phase I' study, which means it’s one of the first steps in testing a new form of a medicine called Nicorandil 40 mg. The goal is to understand exactly how this medicine acts in the body. Specifically, researchers want to see how much of the medicine gets into your system and how quickly, both when you’ve eaten and when you haven’t. This helps them work out the best way for patients to take the medicine in the future. Healthy adult volunteers are needed for this study. It's a key part of developing new treatments, helping doctors decide how medicines should be used safely and effectively for those who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Auxilius Pharma Sp. z o.o.

Enrolment target

Start

03 Nov 2023

No medical condition.

What is this study about?

Imagine a new type of medicine that helps your heart. Before it can be given to people with heart problems, scientists need to understand how it works in the body. This study is doing exactly that for a medicine called Nicorandil 40 mg. It's an 'extended-release' capsule, which means it's designed to release the medicine slowly over time.

The main aim is to see how the body handles this medicine. This includes looking at how it's absorbed into the bloodstream, how it's processed, and how it eventually leaves the body. The researchers are especially interested in whether these things change if you take the medicine with food compared to taking it on an empty stomach.

This kind of research is really important because it helps doctors and pharmacists figure out the best way for patients to take the medicine – for example, whether it should be taken with or without food. This understanding helps make sure the medicine works as well as possible and is safe for people who might need it in the future.

Key takeaways

This study helps understand how a heart medicine (Nicorandil) works in the body.
It's for healthy adults aged 18 and over.
Researchers want to see if food affects how the medicine is absorbed.
Your participation helps develop future treatments.
You would have blood tests and health checks.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults to take part. Being 'healthy' means you don't have any major medical conditions that would affect how the medicine works in your body. This includes conditions like heart problems, diabetes, or serious kidney or liver issues.

You need to be at least 18 years old to join. There isn't an upper age limit, meaning older adults can also take part as long as they meet the other health requirements. Both men and women are welcome to participate in this study.

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 at least 18 years old?
Are you generally healthy with no major ongoing medical conditions?
Are you able to attend clinic visits for tests?
Are you willing to follow specific instructions about food and other medicines?
Are you happy to provide blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the Nicorandil 40 mg medicine. You'll likely have some visits to a clinic where doctors and nurses will monitor you closely. This will involve giving blood samples at different times to see how the medicine is moving through your body. You might take the medicine once on an empty stomach and another time after eating, with a break in between.

There won't be many different medical tests, mainly blood samples and general health checks like blood pressure and heart rate. We don't have details on the exact number of visits or the total length of the study here, but these details would be fully explained to you before you agree to participate. You'll also be asked not to take certain other medicines or foods during the study.

Potential risks and benefits

The main benefit of taking part in a study like this is helping advance medical knowledge, which could lead to better treatments for others in the future. You will also receive careful medical attention during the study. Potential risks are generally low in early-stage studies with healthy volunteers, but could include minor discomfort from blood draws, or possible side effects from the study drug, which would be explained in full. Remember, taking part is always voluntary, and you can change your mind and withdraw from the study at any time without needing to give a reason, and it won't affect your future 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
Portugal

Common questions

What is Nicorandil?

Nicorandil is a medicine that can help with certain heart conditions by widening blood vessels, allowing more blood to flow.

Why do studies use healthy volunteers?

Using healthy volunteers helps researchers understand how a medicine works in the body without other health problems complicating the results. This is a first step before testing in people with specific illnesses.

What does 'extended-release' mean?

It means the medicine is designed to be released slowly into your body over a longer period, so you don't have to take it as often.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and travel, but specific details would be given when you are told more about the study.

Is this a new medicine?

Nicorandil isn't new, but this study might be looking at a new way of taking it or a new formulation (like an extended-release version).