Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fed condition

Researchers are conducting a study to compare a new 6mg deucravacitinib tablet made by Sun Pharmaceutical Industries Limited with the existing Sotyktu (deucravacitinib) 6mg tablet from Bristol-Myers Squibb. The main goal is to see if these two versions of the medicine are absorbed and behave the same way in the body. This is called a 'bioequivalence' study. Healthy adult volunteers will take a single dose of each medication at different times, with food. This type of study is fundamental in making sure new generic or alternative medications work just as effectively and safely as the original.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Sun Pharmaceutical Industries Limited

Enrolment target

Start

19 Feb 2026

plaque psoriasis

What is this study about?

This research study is about a medicine called deucravacitinib, which is used to treat a skin condition known as plaque psoriasis. You might know the original version of this medicine by its brand name, Sotyktu. The study wants to find out if a new version of deucravacitinib tablets, made by a different company called Sun Pharmaceutical Industries Limited, works in the same way your body processes the original Sotyktu tablets.

Think of it like comparing two different brands of a common pain reliever. Even if they have the same active ingredient and strength, scientists need to make sure your body absorbs them in a very similar way. That's exactly what this study, called a bioequivalence study, aims to do for deucravacitinib.

By ensuring the new version acts the same in the body, health authorities can be confident that it will be just as safe and effective for people with plaque psoriasis. This is an important step before a new medication can become widely available.

Key takeaways

Compares a new deucravacitinib tablet with the existing Sotyktu.
Aims to ensure both medicines are absorbed similarly by the body.
Involves healthy adult volunteers, aged 18 or over.
Participants will take a single dose of each medicine at separate times, with food.
Blood samples will be taken to measure drug levels.
Crucial for bringing new, equivalent medicines to market.

Who may be eligible?

To join this study, you must be a healthy adult, 18 years old or older. The study welcomes both men and women.

Since this study focuses on how the body handles the medicine, it's designed for people who are generally well. They will check to make sure you don't have any major health problems that could affect how the medication works or might put you at risk.

You will also need to be able to follow all the study instructions, which will include coming to clinic visits and taking the medication as directed.

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 able to attend several clinic visits?
Are you willing to have blood samples taken?
Are you comfortable taking a study medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to visit a research clinic several times. During your visits, you will receive a single dose of one of the deucravacitinib tablets (either the new version or the Sotyktu tablet) after you've eaten a meal. On a separate visit, you'll then receive the other tablet, also after a meal. This 'crossover' design allows researchers to compare both medicines in the same person.

Throughout these visits, doctors and nurses will regularly take blood samples to measure how much of the medicine is in your body over time. They will also check your general health and may ask you about any effects you experience. The total duration of your active participation, including all visits and follow-up, will be explained in detail.

Potential risks and benefits

The main benefit of participating in this study is contributing to medical science, which helps bring new or alternative medications to people who need them. As this is a study with healthy volunteers, there are no direct health benefits to you from the medication itself. Potential risks include discomfort from blood draws, possible side effects from the medication, which will be fully explained, and the demand on your time. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

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

What is plaque psoriasis?

Plaque psoriasis is a common, long-lasting skin condition where cells build up rapidly on the skin's surface, forming thick, silvery scales and itchy, dry, red patches.

What does 'bioequivalence' mean?

Bioequivalence means that two different versions of a medicine act essentially the same way in the body. They deliver the same amount of the active ingredient to your bloodstream at a similar rate, meaning they should work just as well.

Why do healthy people take part in these studies?

Studies like this use healthy volunteers to clearly see how the body absorbs and handles the medicine without other health conditions affecting the results. This makes it easier to compare the medications accurately.

Will I know which medicine I'm taking?

This is an 'open-label' study, which means both you and the study team will know which version of the medication you are receiving on each visit. However, you will take both medicines at different times.

Will this study help my psoriasis?

This study is for healthy volunteers and is not designed to treat psoriasis. Its purpose is to compare how two different versions of a medication are processed by the body.