An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Tamsulosin Hydrochloride Capsules USP 0.4 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Tamsulosin Hydrochloride extended-release capsules 0.4 mg, Product of Geolab Indústria Farmacêutica S/A, VP. 1B QD.08-B Modules 01 to 08, DAIA - Anápolis – GO, in healthy adult, human male subjects under fed condition.
This study is looking at two types of a medicine called Tamsulosin Hydrochloride, which helps men with an enlarged prostate. Researchers want to see if a new version of the medicine works in the same way as an existing one. They will compare how the medicines are absorbed into the body and how long they stay there. This type of study, called a bioequivalence study, helps ensure that different versions of a medicine have the same effect. Healthy adult men will take a single dose of each medicine, separately, after a meal, so scientists can compare them fairly.
At a glance
What is this study about?
This study is about a medicine called Tamsulosin Hydrochloride. This medicine is commonly used to help treat symptoms of an enlarged prostate gland in men, also known as Benign Prostatic Hyperplasia (BPH). When the prostate gland gets bigger, it can press on the tube that carries urine out of the body, making it difficult to pee. Tamsulosin Hydrochloride helps to relax the muscles in the prostate and bladder, making it easier to pass urine.
The main goal of this particular study is to compare two different versions of Tamsulosin Hydrochloride capsules. One is already available, and the other is a new version made by a different company. Because medicines can be made by various manufacturers, it's important to make sure that each version works in exactly the same way in the body. This study aims to check if the new version is 'bioequivalent' to the established one, meaning it's absorbed and used by the body in the same way, and therefore expected to have the same effect.
This kind of study is really important for patient safety and confidence. If two medicines are bioequivalent, doctors and patients can be confident that using either one will achieve the same results. This study is an early-stage study, meaning it helps gather basic information about how the medicines behave in healthy people before they are regularly used in patients.
Key takeaways
- Compares two versions of a common prostate medicine.
- Ensures new versions work just like established ones.
- Only healthy adult men can participate.
- Involves taking single doses of medicine over time.
- Helps make sure medicines are safe and effective for patients.
Who may be eligible?
This study is specifically looking for healthy adult men to take part.
To be considered for the study, you must be at least 18 years old. There isn't an upper age limit mentioned, but you would still need to be in good general health.
Because this medicine is for an enlarged prostate and the study wants to be sure it's comparing the medicines fairly in healthy people, women would not be eligible to participate.
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 male?
- Are you 18 years old or older?
- Are you generally in good health?
- Are you able to attend clinic visits as required?
What does participation involve?
If you decide to take part, you would receive a single dose of one version of the study medicine. Some time later, you would then receive a single dose of the other version of the study medicine. This is done to compare how both medicines act within your own body. Each time you take the medicine, you will do so after eating a meal.
Between taking the two different medicines, there will be a 'washout period' where you don't take any study medication. This lets your body completely clear the first medicine before you take the second. You would have several visits to the study clinic, typically including blood tests to measure how the medicine is absorbed and cleared from your body. The total duration of your involvement in the study, from your first visit to your last follow-up, will be explained to you, but typically these types of studies involve a few clinic visits over a few weeks.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What is tamsulosin hydrochloride used for?
It's a medicine often used to help men with symptoms of an enlarged prostate, making it easier to pee.
Why is this study comparing two versions of the same medicine?
The study checks if a new version of the medicine works in exactly the same way as an existing one in the body.
Who can take part in this study?
Healthy adult men, aged 18 or older, can take part.
Will I have to take the medicine every day?
No, you'll take a single dose of each medicine at different times, after a meal, during the study visits.
Is this a new medicine that's never been used before?
No, the medicine itself is already known; this study is comparing a new manufacturer's version to an existing one.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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