Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomized, open-label, single dose, cross-over study to evaluate the drug-drug interaction between Proscar 5 mg, film-coated tablets and Cialis 5 mg film-coated tablets when co-administered versus the administration of each product alone in healthy volunteers under fasting conditions. Study no. FIN-TAD-DDI-03-24

This study is designed to understand how two medicines, Proscar (used for prostate issues) and Cialis (used for erectile dysfunction), interact with each other in the body. Researchers want to see if taking them at the same time changes how each medicine works, compared to taking each one on its own. This is done by giving healthy men both medicines separately and then together, and carefully measuring the effects. It's a very early stage study, often called Phase I, which helps ensure medicines are safe and work as expected before they are given to more people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

11 Mar 2024

healthy male subjects

What is this study about?

Imagine you sometimes take two different medicines for different reasons. This study is like a careful observation to see what happens when those two specific medicines, Proscar and Cialis, are taken together in healthy people. Proscar is often used to treat an enlarged prostate, while Cialis is used for erectile dysfunction.

The main goal is to check for something called a 'drug-drug interaction.' This simply means figuring out if one medicine changes how the other medicine works in your body – for example, if it makes it stronger, weaker, or changes how quickly your body gets rid of it. Understanding these interactions is really important for doctors to know the safest and most effective way to prescribe medicines.

This is a very early stage study, often called a Phase I study. These studies are crucial because they help scientists learn about a medicine's basic safety and how it behaves in the body before it's given to a larger group of people. By using healthy volunteers, researchers can focus purely on how the medicines interact without other health conditions getting in the way.

Key takeaways

This study examines how Proscar and Cialis interact when taken together.
It involves healthy adult men aged 18 and over.
The study assesses medicine levels in your body under fasting conditions.
It's an early-stage study to gather important safety information.
Participation involves taking medicines and providing blood samples.

Who may be eligible?

To be able to take part in this study, you would need to be a healthy man. The study is specifically looking for people who are generally well and don't have any major ongoing health problems.

There isn't an upper age limit mentioned, but you must be at least 18 years old. This means that men of adult age, who are in good health, could be considered for 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 a man?
Are you 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you willing to follow specific instructions, including fasting?

Answer every question to see your result.

What does participation involve?

This study is designed as a 'cross-over' study. This usually means you would receive one treatment, then after a break, you would receive the other treatment. For this study, you might take Proscar alone at one point, Cialis alone at another, and then both together at a different time. Each of these 'treatment periods' would be separated by a 'washout' period where you wouldn't take any study medicines.

You would likely need to visit the study clinic several times. These visits would involve taking the medicines as instructed, having blood samples taken to measure how the medicines are moving through your body, and possibly having other health checks. You would need to follow specific instructions, including fasting (not eating) before taking the medicines. The total length of your involvement in the study, including all treatment periods and breaks, would be explained to you in detail.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of this study is helping researchers gain important knowledge about how these medicines interact, which could lead to safer prescribing practices in the future. However, there is no direct personal health benefit for you from participating. Potential risks might include experiencing side effects from the medicines, discomfort from blood draws, or inconvenience from the study visits. You will receive a full explanation of all known risks before you decide to join. Remember, taking part in a clinical study is always voluntary, and you have the right to withdraw at any time without giving a reason.

Locations (1)

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

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Unverified
Czechia

Common questions

What is the main purpose of this study?

The main purpose is to see how Proscar and Cialis affect each other in the body when taken together, compared to taking them separately.

Who can take part in this study?

Only healthy men, aged 18 or older, can take part in this study.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain period before taking the study medicines, to make sure food doesn't affect the results.

Is this a new medicine being tested?

No, both Proscar and Cialis are medicines that are already approved and widely used. This study is looking at how they interact.

Will I get free treatment for a health condition?

This study is for healthy volunteers and is not aimed at treating a specific health condition of your own. The goal is to gather information about drug interactions.