Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioavailability study with naloxone hydrochloride in healthy volunteers

This research study is about a medicine called naloxone hydrochloride. It's a very early stage study, meaning it's being conducted in healthy volunteers rather than people with a specific illness. The main goal is to understand how the body handles this medicine. Researchers want to know how much of the medicine gets into the bloodstream and how quickly, as well as how the body gets rid of it. This type of study, called a 'bioavailability' or 'bioequivalence' study, is a standard part of developing new medicines. It helps scientists understand if different versions of a medicine are working in the body in the same way. This particular study is not looking to treat any health conditions, but rather to gather important information for future use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Vaccpower Limited

Enrolment target

Start

10 Feb 2026

No therapeutic indication in the current trial with healthy volunteers.

What is this study about?

This research study is focused on a medicine known as naloxone hydrochloride. Imagine you take a tablet – this study aims to understand what happens to that medicine once it enters your body. Specifically, it's looking at how much of the medicine gets into your bloodstream and how quickly your body uses it or gets rid of it. This is really important information for pharmaceutical companies that make medicines.

This type of study is called a 'bioavailability' study, sometimes also known as 'bioequivalence'. It's one of the very first steps in testing a new medicine or a new version of an existing medicine. Instead of trying to treat a specific illness, these studies are all about understanding the medicine itself. Think of it like testing a car's engine to see how efficiently it uses fuel, rather than testing it on a race track.

Because this is such an early stage study, it involves healthy volunteers. This means people who don’t have any particular health problems related to the medicine being studied. By testing in healthy people, researchers can get a clear picture of how the medicine behaves without other health conditions getting in the way. The information gathered from this study helps ensure that medicines are effective and safe for people who might need them in the future. It's a crucial step in bringing new, important treatments to patients.

Key takeaways

This study is about a medicine called naloxone hydrochloride.
It's an early-stage study in healthy volunteers, not for treatment.
The goal is to understand how the body uses the medicine.
It's an important step in developing new medicines.
Anyone 18 or older, male or female, can potentially take part.
Your contribution helps medical science.

Who may be eligible?

Researchers are looking for volunteers aged 18 years and older to take part in this study. There is no upper age limit, meaning people of all adult ages can be considered.

The study welcomes both men and women to participate. The key requirement is that you are healthy, as this study is not designed for people with specific medical conditions. They want to see how the medicine works in a general healthy body.

More specific details about what 'healthy' means for this study would be explained by the research team. This might include checking you don't take certain medications or have specific health issues that could affect the results.

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?
Are you generally in good health?
Are you comfortable with taking study medication?
Are you comfortable with having regular blood tests?
Are you able to commit to the study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a screening visit to check if you are suitable. If you qualify, your participation would involve a few visits to the study clinic. During these visits, you would receive the study medication (naloxone hydrochloride). They would then regularly take small blood samples to see how the medicine is moving through your body over time. You might also have other checks like blood pressure and heart rate measurements. The total duration of your involvement, including all visits and follow-up, would be fully explained before you agree to participate.

Potential risks and benefits

Participating in any research study has both potential benefits and potential risks. A potential benefit of taking part in this study is contributing to medical science, which can help develop safer and more effective medicines for future patients. You would also receive medical checks during your involvement. Regarding risks, there's always a chance of experiencing side effects from the study medication, although these early-stage studies are designed with safety as a top priority. There might also be minor discomfort from blood tests. You will be given a full explanation of all known potential risks before you decide to join. Remember, 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
Bulgaria

Common questions

What is naloxone hydrochloride?

Naloxone hydrochloride is a medication that is being studied. This particular trial is just looking at how the body handles it, not using it to treat any illness.

Why are you testing this on healthy people?

Testing on healthy volunteers helps researchers understand exactly how the medicine works in the body without other health problems affecting the results. It's a standard first step in drug development.

Will this drug treat any illness I have?

No, this study is not designed to treat any health conditions. Its purpose is purely to gather information on how the medicine is absorbed and used by the body.

What does 'bioavailability study' mean?

It means the study is looking at how much of the medicine gets into your bloodstream and how quickly your body uses or gets rid of it. It's about understanding the medicine's journey inside you.

Will I be paid to take part?

Information about payment for your time and expenses would be fully explained by the research team if you are invited to participate.