Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

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

This study is designed to compare two different Tiotropium inhalers. Tiotropium is a medicine often used to help people with breathing problems. However, for this study, we are looking for healthy volunteers, not people with a medical condition. The main goal is to find out if the two inhalers deliver the medicine into the body in a very similar way, which we call 'bioequivalence'. This is a common step for new medications to ensure they are just as effective as existing ones. Your participation would help us understand if these different versions of the inhaler work similarly.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Invox Belgium

Enrolment target

Start

07 Oct 2024

No therapeutic indication in the current trial with healthy volunteers.

What is this study about?

Imagine you have two different brands of a popular drink, but they both contain the same main ingredients. This study is a bit like that, but for inhalers. We want to see if two different inhalers, both containing the medicine Tiotropium, deliver the medicine into the body in almost exactly the same way. Tiotropium is a medicine used for long-term breathing conditions, but for this specific study, we're not looking at treating a condition. Instead, we're doing a "bioequivalence" study.

"Bioequivalence" simply means checking if two medicines, even if they look a bit different or come in different devices, act the same way in your body. This is really important to make sure that a new version of an inhaler will be just as safe and effective as an existing one. By taking part, healthy volunteers help us gather this important information. It means that if one of these inhalers eventually becomes available to patients, doctors can be confident it will work reliably.

Participating helps us ensure that future medication options are well-understood and meet high standards. It's a key step in bringing new or improved medicines to people who need them.

Key takeaways

Compares two different Tiotropium inhalers.
Uses healthy adult volunteers.
Aims to see if inhalers deliver medicine similarly.
Helps ensure future medicines are safe and effective.
No direct health benefits for participants.
You can stop at any time.

Who may be eligible?

This study is looking for healthy adults. This means you should generally be well and not have any ongoing serious health problems.

You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, so older adults who are otherwise healthy may also be able to join.

Both men and women are welcome to participate in this study. The researchers will check your health carefully to make sure it's safe for you to 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?
Do you have any serious ongoing medical conditions?
Are you willing to follow study instructions and attend appointments?
Are you comfortable with blood samples being taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the clinic a few times. During these visits, you'll receive doses from the two different Tiotropium inhalers at different times. The researchers will take blood samples regularly to measure how much of the medicine is in your body after each dose. They might also do other health checks like measuring your heart rate or blood pressure.

It's likely that you will receive each inhaler several times to ensure accurate comparisons. You'll be carefully monitored by the study team throughout your participation. The total time you would be involved in the study, including all visits and follow-up, would be made clear to you before you agree to join.

Potential risks and benefits

The main benefit of taking part is contributing to medical research that helps ensure new medicines are safe and work as expected for future patients. For healthy volunteers, there isn't a direct health benefit. Potential risks include discomfort from blood draws, and there's always a chance of mild and usually temporary side effects from the study medication, even in healthy people. However, Tiotropium has been widely used, and the doses in this type of study are carefully controlled. 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 Tiotropium used for normally?

Tiotropium is a medicine that helps people with certain long-term breathing conditions to breathe more easily.

Why aren't you studying people with breathing problems?

This particular study focuses on how the body handles the medicine, not on treating a condition. Using healthy volunteers helps us see the medicine's effects clearly without other health issues interfering.

Will I have to stay overnight?

The study team will explain all the details, including whether any overnight stays are needed, before you agree to take part. This can vary between different studies.

Will I get paid for taking part?

It's common for studies involving healthy volunteers to offer payment to cover your time, travel, and inconvenience. The study team will provide full details if this is offered.

What does 'Phase I' mean?

'Phase I' means it's an early stage of testing for a medicine. In this case, it's a specific type of Phase I study called a bioequivalence study, which looks at how the body deals with the medicine.