Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study between two fluticasone propionate 500μg/salmeterol 50μg inhalation powders

This study is looking at a new version of an inhaler that contains two medicines: fluticasone propionate (500μg) and salmeterol (50μg). These medicines are used together to treat breathing conditions like asthma and chronic obstructive pulmonary disease (COPD). The main goal is to see if the new inhaler works in the exact same way as the original, approved version. This is called a 'bioequivalence study'. They will test this on healthy adult volunteers to make sure the body absorbs the medicine from both inhalers in the same way. This helps ensure that the new inhaler will be just as effective and safe for patients as the current treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Respirent Pharmaceuticals Co. Ltd.

Enrolment target

Start

13 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 research study is about an inhaler that's commonly used to help people with asthma and a lung condition called COPD. This inhaler contains two important medicines: one is a type of steroid (fluticasone propionate) that reduces swelling in the airways, and the other is a long-acting bronchodilator (salmeterol) that helps open them up.

The main purpose of this study is to compare a new version of this inhaler with the original one. It's like checking if a generic brand of a medicine works exactly the same as the well-known original. Scientists do these types of studies, called 'bioequivalence studies', to make sure that any new version of a medicine delivers the same amount of medicine into your body and works just as effectively and safely as the current medicine you might be using.

This is a crucial step before a new medicine can be made widely available. By making sure different versions of the same medicine act identically in the body, doctors and patients can be confident that they are getting consistent treatment, no matter which approved version of the inhaler they use. This study helps ensure the quality and effectiveness of inhaler treatments for people who need them.

Key takeaways

This study compares a new inhaler to an existing one.
It aims to confirm both work identically in the body.
Healthy adults aged 18 and over can participate.
It helps ensure new versions of medicines are safe and effective.
You won't be treated for asthma or COPD in this study.

Who may be eligible?

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

To be included, you need to be at least 18 years old. There's no upper age limit for how old you can be. Both men and women can 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 healthy with no serious ongoing medical conditions?
Are you able to attend study visits as required?
Are you comfortable with blood tests?
Are you not currently on regular medication for asthma or COPD?

Answer every question to see your result.

What does participation involve?

While the detailed steps are not provided, typically, taking part in a study like this involves several visits to a clinic. You would likely receive doses of both the original and new inhalers, usually on different days. Doctors and nurses would then take blood or urine samples regularly over a set period after each dose to measure how much medicine is in your body and how quickly it's absorbed and goes away. These visits might last several hours or even a full day. The total duration of your involvement could range from a few days to a few weeks, depending on the number of comparisons needed.

Potential risks and benefits

Potential benefits of taking part could include contributing to scientific knowledge that helps ensure safe and effective medicines are available to patients. You might also receive payment for your time and travel. Potential risks, though usually low in healthy volunteer studies, could include mild side effects from the medication, such as a headache, or discomfort from blood draws. You will be told about all known risks before you decide to take part. Remember, you can choose to leave 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
Greece

Common questions

What is a 'bioequivalence study'?

It's a type of study that checks if two different versions of a medicine act the same way inside the body. It helps ensure a new version is just as good as the original.

Who is this inhaler usually for?

This type of inhaler is typically prescribed for people aged 4 and older with asthma, and for adults with chronic obstructive pulmonary disease (COPD) to help manage their breathing.

Will I have to stop my current medicines if I join?

If you are on any other medications, especially for asthma or COPD, you will receive specific instructions. This study involves healthy volunteers, so you wouldn't usually be on regular treatment for these conditions.

What will I get for taking part?

Compensation for your time, travel, and inconvenience is usually provided for healthy volunteer studies. The exact amount would be explained at your first visit.

Is this a new medicine not yet used by anyone?

No, the medicines themselves (fluticasone propionate and salmeterol) are already established treatments. This study is testing if a *new version* (like a generic) of the existing combination inhaler works the same.