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 fasting condition.
This study is a Phase 1 bioequivalence trial comparing two versions of a medicine called mesalamine. Mesalamine is widely prescribed to reduce gut inflammation in people with ulcerative colitis. The goal of this research is to show that a capsule made by Sun Pharmaceutical works in the exact same way as an already approved version made for Teva Pharmaceuticals. Instead of enrolling people with bowel disease, this trial involves healthy adult volunteers. Participants will take a single 400 mg capsule on an empty stomach across four separate study periods. Over the course of the trial, blood samples are collected to measure how fast each version enters the bloodstream and how long it stays there. Studies like this are vital. They help confirm that new, more affordable versions of standard medicines are safe, effective, and fully interchangeable with established treatments.
At a glance
What is this study about?
Mesalamine is a well-established medication used to manage ulcerative colitis, a long-term condition that causes inflammation and sores in the bowel. To help keep treatment affordable and widely accessible, pharmaceutical companies develop alternative versions of approved medicines. These are known as bioequivalent medicines, and they must contain the exact same active ingredient and work in the same way.
This clinical study compares two 400 mg delayed-release mesalamine capsules: one made by Sun Pharmaceutical and an approved version made for Teva Pharmaceuticals. The term 'delayed-release' means the capsule is specially coated so it does not dissolve in the stomach. Instead, it travels safely into the gut before releasing the medicine right where it is needed most.
Researchers want to confirm that the body absorbs both brands at the same speed and in the same amount. To do this, healthy volunteers take each brand on an empty stomach at different times. Frequent blood checks will show how the body processes both capsules. If the results match, doctors and patients can be confident that the new version works just as reliably as the original.
Key takeaways
- Compares two brands of mesalamine 400 mg capsules to ensure they work the same way.
- Open to healthy adult volunteers aged 18 and over, not people with bowel disease.
- Involves four separate dosing sessions taken on an empty stomach.
- Regular blood tests will measure medicine levels in the bloodstream.
- Helps make safe, affordable bowel disease medicines available to the public.
Who may be eligible?
This trial is open to healthy men and women aged 18 and older. Because it is an early-stage study designed only to measure how a drug moves through the body, researchers are not seeking people who currently have ulcerative colitis. Instead, they need volunteers in good general health with no significant long-term illnesses.
Volunteers usually need to have a healthy body weight and normal kidney, liver, and heart function. You will likely be asked about any regular medications, vitamins, or supplements you take, as these can interfere with study tests.
Pregnant or breastfeeding women, as well as people with known allergies to mesalamine, aspirin, or related medicines, will not be able to participate. A thorough health screening will take place before anyone is accepted into the study.
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.
- I am 18 years of age or older.
- I consider myself to be in good general health.
- I do not have ulcerative colitis, kidney disease, or liver problems.
- I am not allergic to mesalamine, aspirin, or similar medicines.
- I am willing to fast overnight and have routine blood samples taken.
What does participation involve?
Taking part involves visiting a specialist clinical research clinic across four separate study periods. In each period, you will arrive having fasted (without eating overnight) and take one single 400 mg capsule with water. You will stay at the clinic for regular health checks and blood draws taken over several hours to track the medicine in your body. There is a resting break of several days between each dose to ensure the medicine has completely cleared from your system before the next visit. Overall, the study involves health screenings, blood tests, brief clinic stays, and a final follow-up check to make sure you remain well.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
Do I need to have ulcerative colitis to join?
No. This particular study is looking for healthy adult volunteers to see how the human body absorbs the medicine.
What does 'fasting condition' mean?
It means you will be asked not to eat food for a set number of hours (usually overnight) before taking the capsule, so food does not alter how the drug is absorbed.
What is a bioequivalence study?
It is a scientific test to prove that two different brands of the same medicine release the drug into your body in the exact same way.
Will I be compensated for my time?
Phase 1 trials with healthy volunteers often provide payment to cover time and travel expenses, though details depend on the specific research clinic.
Can I leave the study early if I change my mind?
Yes. Taking part is completely voluntary. You can choose to stop participating at any time without any penalty.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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