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 fasting condition.
This study is looking at a medicine called tamsulosin, which is used to treat problems with an enlarged prostate gland in men. Researchers want to compare two different versions of this medicine to see if they both work in the same way within the body. Specifically, they are comparing a Tamsulosin Hydrochloride Capsule from Sun Pharmaceutical Industries with a Tamsulosin Hydrochloride extended-release capsule from Geolab Indústria Farmacêutica. This research involves healthy adult men who will take a single dose of each medicine at different times, on an empty stomach, to see how their bodies absorb them. The main goal is to ensure the newer version acts just like the established one.
At a glance
What is this study about?
This research is a 'bioequivalence study' for a medicine called tamsulosin. Tamsulosin is commonly used by men who have a condition called Benign Prostatic Hyperplasia, or BPH. This is when the prostate gland, which is part of the male reproductive system, gets bigger with age. An enlarged prostate can cause uncomfortable urinary symptoms, and tamsulosin helps to relieve these.
When a new manufacturer wants to make a copy of an existing medicine, or an existing medicine is made in a slightly different way, they need to prove that it works just as well as the original. This is where a bioequivalence study comes in. 'Bioequivalence' means that the two medicines are absorbed by the body in the same way and reach the bloodstream in similar amounts and at similar speeds. If they are bioequivalent, doctors can be confident that the new version will have the same effects and safety as the original.
In this particular study, they are comparing a tamsulosin capsule made by Sun Pharmaceutical Industries Limited against an extended-release tamsulosin capsule from Geolab Indústria Farmacêutica S/A. Both contain 0.4mg of the active ingredient. The study aims to make sure that the version from Sun Pharmaceutical Industries works just like the one already widely available, specifically when taken on an empty stomach.
Key takeaways
- The study compares two tamsulosin medicines.
- It aims to prove a new version works like an existing one.
- It involves healthy adult men.
- Medicines are taken on an empty stomach.
- Blood tests will check how the medicine is absorbed.
Who may be eligible?
This study is looking for healthy adult men to take part. This means that you should generally be in good health and not have any serious ongoing medical conditions.
You must be at least 18 years old to be considered for this study. There isn't an upper age limit mentioned, so older adults could also be eligible, provided they meet the other health criteria.
Because the study is focused on how the body handles these specific medications, it's only open to men. Women and children would not be able 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 a man?
- Are you 18 years old or older?
- Are you generally in good health?
- Are you willing to take medicine on an empty stomach?
- Are you able to provide blood samples?
What does participation involve?
If you decide to take part in this study, you would receive two different versions of the tamsulosin medicine at different times. This is called a 'crossover' study. First, you'd receive one version, and then after a break, you'd receive the other. Both times, you would take the medicine on an empty stomach. Researchers would regularly take blood samples to measure how the medicine is absorbed into your body and how long it stays there. You would also have check-ups to make sure you are feeling well and that the medicine isn't causing any unexpected side effects. The exact number of visits, tests, and the total duration would be explained in full detail by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is tamsulosin for?
Tamsulosin is a medicine often prescribed to men with an enlarged prostate gland (BPH) to help with urinary problems.
Why are they comparing two different medicines?
Researchers are comparing two versions of tamsulosin to make sure a new version works exactly the same way as an existing one in the body.
Do I have to have an enlarged prostate to join?
No, this study is looking for healthy men, not men with prostate problems, to see how their bodies absorb the medicine.
What does 'on an empty stomach' mean?
It means you would take the medicine after a certain period of not eating, usually overnight, to ensure consistent absorption.
Will I know if I'm taking the 'new' or 'old' version?
Yes, in this type of study ('open label'), both you and the researchers will know which version of the medication 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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