An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fed condition.
This study is looking at two versions of a medicine called mesalamine, which is used to treat ulcerative colitis. One version is made by Sun Pharmaceutical Industries Limited in India, and the other by Teva Pharmaceuticals in the USA. We want to see if these two different brands of mesalamine capsules deliver the medicine into the body in the same way. Healthy adult volunteers will take a single dose of each medicine at different times, while having eaten beforehand. This helps us understand if both versions are equally effective at getting the medicine where it needs to go.
At a glance
What is this study about?
This study is focused on a medicine called mesalamine, which is often prescribed to people with ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine.
When a medicine is developed, different companies might make their own versions. It's really important to make sure that all versions of a medicine work in the same way in the body. This study, called a bioequivalence study, is designed to compare two specific brands of mesalamine capsules (both 400 mg strength) to see if they are essentially the same in how they release the medicine into your system.
By ensuring these different brands behave similarly, doctors and patients can be confident that they are receiving consistent treatment, no matter which approved version of the medicine they take. This study is an early-stage study, using healthy volunteers to understand the medicine's behaviour, which is a common and important step in ensuring medicines are safe and effective.
Key takeaways
- This study compares two different brands of mesalamine capsules.
- It's for healthy adults, aged 18 and over.
- The goal is to see if the medicines work the same way in the body.
- Participants will take single doses of each medicine after eating.
- Your involvement helps ensure consistent medicine quality for patients.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be a healthy adult aged 18 years or older. There is no upper age limit mentioned, so adults of all ages, as long as they are healthy, might be able to take part.
Both men and women are welcome to participate in this study. The researchers are looking for a broad range of healthy adults to ensure their findings are widely applicable.
Because this is an early-stage study testing how a medicine acts in the body, it's important that participants are generally healthy and don't have existing conditions that could affect how the medicine works or that could make their participation unsafe.
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?
- Are you prepared to attend multiple clinic visits?
- Are you comfortable with blood tests during the study?
- Are you able to take study medication after meals?
What does participation involve?
If you decide to take part, you'll be asked to visit the clinic multiple times. During these visits, you will receive a single dose of one of the mesalamine capsules, and then, at a later date, a single dose of the other mesalamine capsule. You will be asked to eat a meal before taking the medicine in both cases. The study is structured in four periods with two different sequences, meaning you'll take each medicine at different times. Throughout the study, medical staff will take blood samples and monitor you closely to see how your body processes the medicine. The total duration of your involvement will be spread out over several weeks, involving a few visits followed by a short break, then more visits.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What is mesalamine normally used for?
Mesalamine is a medicine commonly used to treat a condition called ulcerative colitis, which causes inflammation in the large intestine.
Why is it important to compare different brands of the same medicine?
It's important to ensure that different brands of the same medicine work exactly the same way in the body, so patients always get a consistent and effective treatment.
Will I get to know which brand of medicine I received?
Yes, this is an 'open label' study, which means both you and the study team will know which brand of mesalamine you are taking at each stage.
Do I need to have ulcerative colitis to join this study?
No, this study is looking for healthy adult volunteers, not people with ulcerative colitis.
What does 'fed condition' mean in this study?
It means you will take the medicine after eating a meal, as food can sometimes affect how the body absorbs medication.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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