AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

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.

Mesalamine is a common medicine used to treat and manage ulcerative colitis, a condition that causes swelling in the gut. When a company makes a new generic version of a medicine, scientists must check that it acts in the exact same way as the version already in use. This is called a bioequivalence study. In this trial, researchers are comparing two 400 mg mesalamine capsules made by different manufacturers: Sun Pharma and Teva. Because food can change how drugs are absorbed, volunteers will take the capsules after a meal. Healthy adults aged 18 and over will take single doses across four separate test periods. Blood samples will be taken to measure how much medicine enters the bloodstream and how quickly. Studies like this ensure that generic medicines are just as safe and reliable as established brands, giving patients and the NHS more treatment options.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Sun Pharmaceutical Industries Limited

Enrolment target

112

Start

12 Oct 2026

Ulcerative colitis

What is this study about?

Ulcerative colitis is a long-term condition where the lining of the large bowel becomes red, inflamed, and ulcerated. Mesalamine is an anti-inflammatory medicine that works directly in the gut to reduce this swelling, calm flare-ups, and keep symptoms away. To work properly, the capsules are specially designed to release the active medicine only when they reach the bowel.

When a drug company produces a new generic version of an approved medicine, it must prove that the new product works identically to the original. This clinical trial compares a mesalamine 400 mg capsule made by Sun Pharmaceutical with an approved version made by Teva. The main goal is to show that both versions release the medicine into the body at the same speed and in the same amount.

This kind of research is vital for public health. When generic medicines are proven to match brand-name drugs, healthcare systems like the NHS can offer high-quality treatments at a lower cost. It also helps prevent medication shortages by making sure there are multiple reliable makers of essential medicines.

Key takeaways

The study compares two 400 mg mesalamine capsules to check they work identically in the body.
Mesalamine is an anti-inflammatory drug used to manage ulcerative colitis.
The trial is open to healthy adult volunteers aged 18 and older.
Volunteers will take single doses after a meal across four separate study periods.
Taking part involves clinic visits and blood tests to monitor medicine levels.

Who may be eligible?

This trial is designed for healthy adult volunteers aged 18 and older, including both men and women. Because this is an early-stage pharmacology study looking purely at how the body processes the tablet, researchers are looking for people who do not have ulcerative colitis or other active medical conditions.

To ensure results are clear and volunteers stay safe, participants must generally be free from serious long-term illnesses, such as kidney, liver, or heart problems. Volunteers should not have known allergies to mesalamine, aspirin, or similar anti-inflammatory medicines.

Women who are pregnant, planning to become pregnant, or breastfeeding will not be able to join. The study team will carry out standard medical checks, such as blood tests and an examination, before confirming if you are suitable to take part.

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 an adult aged 18 or older.
I consider myself to be in good overall health.
I do not have a known allergy to mesalamine, aspirin, or related painkillers.
I am not pregnant, planning a pregnancy, or breastfeeding.
I am willing to attend clinic visits, eat test meals, and have regular blood samples taken.

Answer every question to see your result.

What does participation involve?

Taking part involves several visits to a specialized clinical research unit. The trial uses a 'crossover' design with four separate periods. This means you will receive both the test capsule and the comparison capsule on different occasions, with a resting period (called a 'washout') of several days or weeks in between to let each dose fully leave your system. Before each dose, you will be given a standardized meal to eat, as the study tests the medicine under fed conditions. You will take a single capsule with water. During each period, you will need to stay at the clinic for short stays or day visits so the medical team can take regular blood samples and monitor your blood pressure and heart rate. In total, participation usually lasts a few weeks from the initial screening check to the final health review.

Potential risks and benefits

Because you are a healthy volunteer, you will not receive any direct medical benefit from taking the medication. However, your involvement helps ensure that safe, affordable generic medicines reach people living with chronic gut conditions. Most people tolerate mesalamine well, but possible side effects include mild tummy ache, nausea, diarrhoea, or headache. There may also be slight bruising or discomfort from repeated blood samples. Your health will be watched closely by doctors throughout the study, and you have the right to withdraw from the trial at any point without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania

Common questions

Why is this trial being done on healthy people instead of patients?

Healthy volunteers have predictable body processes that are not influenced by active illness or other gut treatments. This makes it much easier to measure the exact way the body absorbs the medicine.

What does 'bioequivalence' mean?

It means two different versions of the same medicine release their active ingredients into the bloodstream at practically the same rate and amount, meaning they should work identically.

Why do volunteers have to take the medicine after eating?

Food in the stomach can change how quickly a capsule breaks down. Testing under 'fed conditions' proves that the medicine releases reliably even when taken after a meal.

Will taking part cost me anything?

No, all study-related tests and medications are provided free of charge. Healthy volunteer studies often provide compensation or travel expenses to cover your time and effort.

Can I leave the study early if I want to?

Yes. Joining a clinical trial is entirely voluntary, and you are free to stop participating at any time.