Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study between two fluticasone propionate 250μg/salmeterol 50μg inhalation powders

This study is looking at two versions of an inhaler used for asthma and COPD. The inhaler contains two medicines: fluticasone propionate and salmeterol. These medicines work together to help people breathe better and reduce flare-ups. The main goal is to check if a new version of this inhaler delivers the medicine into the body in the same way as the established version. This type of study, called a `bioequivalence study`, is important to ensure that when a new version of a medicine is made, it works just as safely and effectively as the original. This particular study is being carried out in healthy volunteers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Respirent Pharmaceuticals Co. Ltd.

Enrolment target

Start

26 Jul 2023

Healthy volunteers.Regular treatment of bronchial asthma, where a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) is indicated for:•Twice-daily treatment of asthma in patients aged 4 years and older.•Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

What is this study about?

This clinical study, known as a `bioequivalence study`, is a common and important step in bringing new medicines to people. When a drug company wants to create a new version of an existing inhaler, they need to show that it works the same way in the body as the original. This isn't a test about whether the medicine itself works, because we already know that these medicines are effective for asthma and COPD.

Instead, this study focuses on how the body handles the medicine once it's inhaled. It compares how much of the medicine gets into the bloodstream and how quickly, from both the new inhaler and the established one. This information helps regulatory bodies, like the MHRA in the UK, make sure that patients receiving the new version will get the same benefits and safety as those using the original.

Ultimately, this research helps ensure that patients have access to reliable and effective treatment options for their asthma and chronic obstructive pulmonary disease (COPD). It's a way of assuring quality and consistency for medicines we rely on every day.

Key takeaways

This study compares a new inhaler with an existing one for asthma and COPD.
It's checking if both inhalers deliver medicine into the body in the same way.
The study takes place in healthy volunteers, aged 18 and over.
Participation helps ensure new medicines are safe and work effectively.
You won't directly benefit from the medicine for a condition, as you need to be healthy to join.

Who may be eligible?

This study is looking for healthy volunteers, meaning people who don't have certain medical conditions. You need to be at least 18 years old to take part.

It's important to remember that even if you meet the basic age requirement and consider yourself healthy, there might be other reasons why you can't join. For example, certain medications you're taking, or past health issues might exclude you.

All potential participants will have a health check-up to make sure the study is right and safe for them. Both men and women are welcome 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?
Do you consider yourself generally healthy?
Are you able to attend several clinic visits?
Are you comfortable with blood samples being taken?
Are you not currently taking medications that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the two different inhaler versions being compared during specific periods. This typically involves several visits to a clinic over a short amount of time. During these visits, medical staff will take blood samples to measure how much of the medicine is in your system. You might also have other check-ups, like blood pressure readings, to monitor your health.

Since this is an early-stage study in healthy volunteers, it's designed to be well-monitored. While the exact number of visits isn't specified, these types of studies often involve overnight stays at a research facility and regular follow-up for a few weeks. The total duration of your involvement could range from a few days to a few weeks, depending on the study design.

Potential risks and benefits

Taking part in a study like this might offer a small payment for your time and contribution to medical science. While there's no direct health benefit for you, as these medicines are for specific conditions you don't have, your participation helps ensure new medicines are safe and effective for future patients. Potential risks are generally low but can include mild side effects from the inhaler medication, discomfort from blood draws, or allergic reactions. All risks will be fully explained, and your safety will be closely monitored. You always have the right to withdraw from the study 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
Greece

Common questions

What does 'bioequivalence' mean?

It means the study is checking if two medicines, even if they look slightly different, work in the same way in your body and deliver the same amount of medicine.

Why is this study being done in `healthy volunteers`?

Early stage studies often use healthy volunteers to see how the body handles the medicine without the complications of illnesses like asthma or COPD affecting the results.

Will I be given the actual asthma/COPD medicine?

Yes, you will be given the inhaler medicines, but the study is about how your body processes them, not about treating a condition you have.

What is `fluticasone propionate` and `salmeterol`?

These are two medicines often combined in an inhaler. Fluticasone reduces inflammation in the airways, and salmeterol helps to open them up, making breathing easier for people with asthma or COPD.

Will I have to stay at a clinic?

These types of studies often involve clinic visits, and sometimes overnight stays, so medical staff can closely monitor you and take samples at specific times.