A double blinded, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine Delayed Release Tablets USP 1.2 g manufactured by Sun Pharmaceutical Industries Limited, India with Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g product of Takeda Canada Inc., in healthy, adult, human subjects under fed condition.
This study is looking at a new version of a medicine called Mesalamine, which is used to treat ulcerative colitis. We are comparing this new version with an existing Mesalamine medicine to see if they are absorbed and work similarly in the body. The study will involve healthy adult volunteers, and they will take the medication after having a meal. This type of study, called a bioequivalence study, helps ensure that new versions of medicines are just as effective and safe as the original, giving you confidence in the treatments available for your condition. It's a key step before new medicines can be widely used.
At a glance
What is this study about?
This study is really important because it checks if a new version of a common medicine for ulcerative colitis, called Mesalamine, works in the same way as a version that is already available. Think of it like comparing two different brands of the same type of painkiller; you want to know that both will do the job equally well. We call this kind of check a 'bioequivalence' study. It's a standard and safe way to make sure that when a new generic medicine comes out, it acts in your body reliably.
The main goal is to see if the new Mesalamine tablets deliver the medicine into your bloodstream at the same rate and to the same amount as the established Mesalamine tablets. This is crucial because it ensures that patients will get the right amount of medication to help manage their ulcerative colitis, no matter which version they take. The study is done in healthy volunteers, which means people who don't have ulcerative colitis, to get a clear picture of how the medicine is absorbed without other health issues complicating the results.
Taking part in a study like this helps improve access to important medicines and ensures that new versions are just as good as what’s already out there. It contributes to making sure you always have effective treatment options for conditions like ulcerative colitis.
Key takeaways
- Compares a new Mesalamine tablet with an existing one.
- Aims to ensure the new version works just as well as the original.
- Involves healthy adults, 18 years and older, both male and female.
- Participants will receive both medicines at different times.
- Helps make new, effective treatments available for ulcerative colitis.
- Strict medical supervision throughout the study.
Who may be eligible?
This study is open to healthy adults who are 18 years old or older. Both men and women can take part. To be considered 'healthy' for a study like this, you would generally be free from any serious medical conditions or recent illnesses that might affect how the medicine works in your body.
Before you can join, there will be a thorough check-up to make sure you are in good health and meet all the specific requirements of the study. This usually involves reviewing your medical history, having some physical examinations, and possibly blood tests.
The main idea is to make sure that the people taking part are healthy enough for the study medication and that their health won't interfere with understanding how the medicine is absorbed.
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, without any serious medical conditions?
- Are you willing to participate in several study visits?
- Are you comfortable with having blood samples taken regularly?
What does participation involve?
If you decide to take part, you'll be involved in a 'crossover' study, which means you'll try both the new Mesalamine and the existing one at different times. The study is divided into four separate visits or stays, each lasting for a short period. During these visits, you'll take a single dose of either the new or existing Mesalamine tablet after eating a meal.
Throughout each visit, healthcare professionals will take regular blood samples to measure how much of the medicine is in your body. This helps them compare how the two versions of Mesalamine are absorbed. You'll switch between the two different medicines over the course of the study, with a break in between, so they can compare the effects of each directly in you. You will also have follow-up checks to ensure you are well.
Potential risks and benefits
Locations (1)
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Common questions
What is Mesalamine used for?
Mesalamine is a medicine commonly used to treat ulcerative colitis, a condition that causes inflammation in the large intestine.
What does 'bioequivalence' mean?
Bioequivalence means that two different versions of a medicine work in the body in the same way and deliver the same amount of medicine at the same rate.
Why is the study done in healthy people?
Doing the study in healthy people helps researchers clearly see how the medicine is absorbed without other health conditions affecting the results, giving a clearer picture of how the drug behaves.
Will I know which medicine I am taking?
No, this is a 'double-blinded' study, meaning neither you nor the study staff will know which version of Mesalamine you are receiving at any given time. This helps keep the results fair and unbiased.
Are there any costs for taking part?
Clinical trial participation is usually free, and sometimes travel expenses or compensation for your time might be offered. This would be fully explained before you agree to join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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