Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A randomized, two-way, crossover, two parallel groups study to compare the bioavailability of 150 mg and 300 mg trazodone hydrochloride tablets (new polymer) (Angelini Pharma S.p.A.) vs. 150 mg and 300 mg trazodone hydrochloride Contramid® tablets (Angelini Pharma S.p.A.) at steady-state

This study is designed to compare two different types of trazodone tablets, a medication often used to treat depression, particularly when anxiety is also present. The researchers want to see how a new version of the tablet is absorbed and used by the body, compared to the current version. They are testing two different strengths: 150 mg and 300 mg. This is a very early stage study (called Phase I) and involves healthy volunteers, meaning people who do not have depression. The aim is to make sure the new tablet delivers the medicine to the body in a similar way to the existing one, which is an important step before it can be considered for patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.

Enrolment target

Start

22 May 2024

Intended indication: Major Depressive Disorders with and without anxiety Healthy volunteers therapeutic indication not studied

What is this study about?

This research study is looking at a medicine called trazodone, which doctors often prescribe to help treat major depression, especially if someone also has anxiety. The company making this medicine is developing a new version of the tablet. This study aims to compare how this new tablet works in the body compared to the version that's already available.

Think of it like this: if you have two different brands of a painkiller, you'd want to make sure they both deliver the same amount of medicine to your body and work in a similar way, even if they look a bit different. That's what this study is doing for trazodone – checking that the new tablet is just as effective at getting the medicine where it needs to go.

This is a very early stage of research, sometimes called a 'Phase I' study. It involves healthy people, not those with depression, because the main goal is simply to understand how the body handles the medicine. It's a crucial step before any new drug or new version of a drug can be considered for wider use by patients. They are testing two common strengths of the medicine, 150 mg and 300 mg.

Key takeaways

This study compares a new version of depression tablets (trazodone) with the current one.
It aims to see if the new tablets are absorbed by the body in the same way.
Healthy adult volunteers are needed, not people with depression.
It's an early-stage research study (Phase I).
Both 150 mg and 300 mg strengths are being tested.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. This means you shouldn't have any major ongoing health problems.

Because this study is about how the medicine is absorbed, it's designed for people who don't currently have major depression or other conditions that trazodone treats. The researchers are looking for healthy volunteers to get the clearest picture of how the drug behaves in the body without other health issues affecting the results. Both men and women can take part.

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 currently NOT being treated for major depressive disorder?
Are you able to commit to several clinic visits?

Answer every question to see your result.

What does participation involve?

While the detailed description wasn't provided, typically for this type of early-stage study involving healthy volunteers and comparing how a drug is absorbed (called bioavailability or bioequivalence), you can expect several visits to a clinic. You would likely take the study medication (either the new or existing trazodone tablet) on specific days. During these visits, blood samples would be taken at various times to measure how much of the medicine is in your system. You might also have brief health checks like blood pressure and heart rate measurements. You would receive both types of tablets at different times during the study to allow for a direct comparison in your own body. The total duration of your involvement could range from a few weeks to a couple of months, including follow-up checks after you stop taking the medication.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science and helping to improve future treatments for depression. You may also receive some compensation for your time and travel. Potential risks could include mild side effects from the medication (even in healthy people), such as drowsiness, dizziness, or nausea, or 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
Germany

Common questions

What is 'trazodone'?

Trazodone is a medicine often used to help people with depression, especially if they also feel anxious.

Why are they studying healthy people if it's for depression?

This early study aims to see how the new tablet is absorbed by the body. Using healthy volunteers helps researchers understand this clearly without other health problems complicating the results.

What does 'steady-state' mean?

It means the study will check the medicine levels in your body after you've been taking it regularly for a few days, so the amount in your system has become stable.

Will I get the new tablet or the old one?

You will likely receive both the new and the existing tablet at different times during the study, allowing researchers to compare them directly in the same person.

Is this a new medicine?

It's a new version (or 'formulation') of an existing medicine, trazodone, not an entirely new drug.