Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study to investigate the similarity of two different Tiotropium inhalers in healthy volunteers.

This study is comparing two different inhalers that contain the medicine called Tiotropium. This medicine is often used for breathing problems, but this particular study is happening with healthy volunteers, not people with lung conditions. The main goal is to find out if these two inhalers deliver the medicine into the body in a very similar way. This is important to ensure that if a new version of a medicine comes out, it acts effectively and safely, just like the original. It's a key step in testing new medicines before they are given to patients who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

invoX Belgium, CCDRD Cooperative Clinical Drug Research and Development AG

Enrolment target

Start

28 Nov 2024

No therapeutic indication in the present bioequivalence trial with healthy volunteers

What is this study about?

Imagine you have a key, and then someone makes a new copy of that key. You'd want to be sure the new key works just as well as the original, wouldn't you? This study is a bit like that, but with inhalers and medicine.

The medicine is called Tiotropium. It's often prescribed to help people with conditions like asthma or COPD (a type of lung disease) breathe more easily. However, this study isn't about treating those conditions. Instead, it's a very early-stage look at two different devices that deliver this medicine.

Researchers want to see if the body handles the medicine from both inhalers in a very similar way. This kind of research, called a 'bioequivalence study,' is a standard and important part of developing new medicines. It helps ensure that any new version of a medicine will work just as well and be just as safe as a medicine that's already widely used. This helps doctors and patients have confidence in the medicines they use.

Key takeaways

Compares two inhalers with the same medicine (Tiotropium).
Study is for healthy adult volunteers, not people with lung conditions.
Aims to see if both inhalers deliver medicine similarly.
An important step in testing new medicines safely.
Participation involves clinic visits and blood tests.
Your contribution helps advance medical understanding.

Who may be eligible?

This study is looking for healthy adults to take part. You need to be at least 18 years old – there's no upper age limit, as long as you're in good general health.

Since this study is about comparing how the body handles the medicine, rather than treating an illness, it's important that participants don't have any major ongoing health problems. Both men and women are welcome to participate in this research.

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 attending clinic visits?
Are you willing to have blood samples taken?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be asked to attend a few appointments at a clinic. At these visits, you'll receive doses of the two different Tiotropium inhalers at different times. Researchers will take blood samples to measure how much of the medicine is in your body and how it's being processed.

Before taking part, you'll have a health check-up to make sure you're healthy enough for the study. There will also be follow-up checks after you've received the medicine. The total duration of your involvement, including all visits and follow-ups, and the full schedule, would be explained to you in detail before you decide to take part.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science and helping to ensure new medicines are safe and effective. While specific personal benefits beyond this are unlikely as the study is not for treatment, you will receive expert medical observation. Potential risks might involve minor discomfort from blood draws or very rare side effects from the study medicine, which would be fully explained. 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.

—
Unverified
Bulgaria

Common questions

What is Tiotropium used for normally?

Tiotropium is a medicine often used to help people with conditions like asthma or COPD (a type of lung disease) breathe more easily by relaxing the airways.

Why are they testing this on healthy people?

They're testing it on healthy people to see how the body handles the medicine from different inhalers without other health conditions making it complicated. This is a standard first step for new medicines.

Will I get treatment for a lung condition?

No, this study is not designed to treat any medical condition. It's purely to compare how two different inhalers deliver the same medicine.

Do I have to take part if I'm interested?

No, expressing interest doesn't mean you have to join. You'll get detailed information to help you decide, and you can change your mind at any point.

What is a 'bioequivalence' study?

It's a study that checks if two different versions of the same medicine act in a very similar way in the body, ensuring they are equally effective and safe.