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 fasting condition.
This study is looking to see if two different brands of mesalamine tablets work in the same way in the body. One tablet is made by Sun Pharmaceutical Industries Limited in India, and the other is a tablet called Mezavant from Takeda Canada Inc. Mesalamine is a common medicine used to treat a bowel condition called ulcerative colitis. This study involves healthy adults who will try each tablet at different times to see how their bodies react to them. It helps to make sure that new medicines being developed are just as effective as ones already available. The study is run in a way that neither the participants nor the researchers know which tablet is being taken at any given time, to ensure fair and accurate results.
At a glance
What is this study about?
Imagine you have a common medicine you take, and a new version of that medicine becomes available. This study is all about making sure that the new version works just as well as the original one. The medicine we're talking about is called mesalamine, which is often used to help people who have a condition called ulcerative colitis. Ulcerative colitis affects the large bowel and can cause symptoms like tummy pain and diarrhoea.
In this study, researchers are comparing two different tablets containing mesalamine. One is a new tablet made in India, and the other is a tablet called Mezavant, which is already used in Canada. The main goal is to see if the body handles both tablets in exactly the same way. This means checking if the medicine gets absorbed into the bloodstream at the same speed and to the same amount from both tablets. If they are very similar, it means the new tablet could be a good alternative.
This type of study is really important because it helps doctors and patients know that different brands of the same medicine will have the same effect. It ensures that when new medicines come onto the market, they are safe and effective. It's a key step in getting new treatments approved and available for people who need them, making sure they can trust their medication.
Key takeaways
- Compares two brands of mesalamine tablets.
- Aims to ensure new medicines work the same as existing ones.
- Involves healthy adults, not people with ulcerative colitis.
- Requires blood samples and fasting.
- Participation helps pharmaceutical development.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or over. This means you shouldn't have any serious ongoing health problems that might affect how your body deals with the medicine.
Both men and women can take part in this study. The most important thing is that you are generally healthy, as confirmed by doctors who will do some checks before you start. They want to make sure the study environment is as consistent as possible so they can accurately compare the two medicines.
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 medical conditions?
- Are you able to follow study instructions, including fasting?
- Are you comfortable having regular blood tests?
- Do you understand that this study is not a treatment for ulcerative colitis?
What does participation involve?
If you decide to take part, you'll be given a single dose of one of the mesalamine tablets. At a later time, you'll receive the other tablet. This allows doctors to compare how your body reacts to both. You'll need to go to a clinic for these doses and for several follow-up blood tests over a few days after each dose. These tests help track how the medicine moves through your body.
This study is conducted under fasting conditions, meaning you won't be able to eat anything for a certain period before taking the medicine. You will attend the clinic for multiple visits, usually over a few separate occasions. These visits will involve taking the study medication, providing blood samples, and having your general health checked. The total time you spend actively in the study will be spread out over several weeks.
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 a bowel condition called ulcerative colitis.
Am I going to be treated for ulcerative colitis in this study?
No, this study is recruiting healthy adults to compare how two different mesalamine tablets work in the body, not to treat the condition itself.
What does 'fasting condition' mean?
It means you will need to avoid eating food for a set period before taking the study medicine, as instructed by the study team.
Why can't I (or the doctors) know which tablet I'm taking?
This is called 'double-blinded' and it helps make sure the study results are fair and accurate, without anyone's expectations influencing the outcome.
How long will I be involved in the study?
You will participate in several separate periods of treatment and follow-up, spread out over a few weeks.
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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