AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-STAGE CROSSOVER ADAPTIVE BIOEQUIVALENCE STUDY OF TRIAMCINOLONE ACETONIDE 40 MG/ML STERILE INJECTABLE SUSPENSION (Test product–Lisapharma S.p.A) VERSUS KENACORT® 40 MG/ML SUSPENSION (Reference product – Bristol Myers Squibb) AFTER INTRAMUSCULAR ADMINISTRATION TO HEALTHY VOLUNTEERS
This research study is looking at a new version of a steroid injection called triamcinolone acetonide, made by Lisapharma. We're comparing it to an existing, well-known version called Kenacort. Both are given as injections into the muscle. The main goal is to check if these two versions of the same medicine are 'bioequivalent'. This means we want to see if they are absorbed into the body and behave in the same way. If they are, it means the new Lisapharma product should work just as effectively and safely as Kenacort. This study is for healthy volunteers aged 18 and over, and it's an important step before the new medicine can be widely used by patients who need it for conditions like severe allergies, skin problems, or certain types of arthritis.
At a glance
What is this study about?
You might be wondering what this study is all about. Well, when a new version of an existing medicine is made, it needs to be checked carefully. This study is doing just that for an injection called triamcinolone acetonide. This medicine is a type of steroid often used to help with serious conditions like severe allergies, troublesome skin problems, or certain forms of arthritis.
The study aims to see if a new version of this medicine, made by a company called Lisapharma, behaves in exactly the same way in the body as the version that's already available, called Kenacort. This comparison is called a 'bioequivalence study'. It's a crucial step to make sure that the new medicine will be just as effective and safe for patients as the original.
To do this, healthy volunteers will receive both injections at different times, and doctors will carefully measure how the medicine is absorbed and processed by their bodies. This helps ensure that if you were prescribed the Lisapharma version, it would work just as well for your condition as the Kenacort version, giving you confidence in the treatment.
Key takeaways
- Compares a new steroid injection (Lisapharma) with an existing one (Kenacort).
- Aims to ensure the new medicine works just as well and is safe.
- Participation involves single muscle injections and blood tests.
- Open to healthy adults, both men and women, aged 18 and over.
- Contributes to important knowledge about new medicines.
Who may be eligible?
To join this study, you need to be a healthy adult, aged 18 years or older. There isn't an upper age limit, meaning older adults can also take part if they are in good health.
This study is looking for both men and women to participate. The most important thing is that you are generally healthy and don't have any serious medical conditions that might affect how your body handles the medicine.
Because this study involves comparing how different versions of a medicine work, it's designed for healthy people. This helps researchers get clear results without other health issues potentially complicating things.
- Are you 18 years old or older?
- Are you generally healthy, without any serious ongoing medical conditions?
- Are you comfortable with having injections into your muscle?
- Are you comfortable with having regular blood tests?
- Are you able to attend several clinic visits for the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be involved in what's known as a 'crossover' study. This means at different times, you'll receive a single injection of the Lisapharma medicine and a single injection of the Kenacort medicine. These injections are given into a muscle, usually in your arm or bottom.
Before each injection, and for a period afterwards, doctors will take blood samples to measure how the medicine is absorbed and processed by your body. You'll also have regular check-ups to monitor your general health and make sure you're feeling well. The study involves a few visits to the clinic, and there will be a resting period between your two injection sessions to allow the first medicine to leave your system before you receive the second one. The total time you'd be involved, from your first visit to your last follow-up, will be explained in detail.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is triamcinolone acetonide?
It's a type of steroid medicine given by injection, used to help with conditions like severe allergies, skin problems, and certain types of arthritis.
Why is this study only for healthy volunteers?
By studying healthy people, researchers can get a clear picture of how the body handles the medicine without other illnesses potentially changing the results.
What does 'intramuscular administration' mean?
It simply means the medicine is given by an injection directly into a muscle, usually in your arm or bottom.
What is a 'bioequivalence study'?
It's a study to check if two different versions of the same medicine are absorbed and work in the body in exactly the same way.
Will I know which injection I'm getting?
Yes, this is an 'open-label' study, meaning both you and the study team will know which version of the injection you are receiving at any given time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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