A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Deucravacitinib 6 mg Tablets in Healthy Adult Subjects Under Fasting Conditions

The primary objective of this study is to evaluate the bioequivalence of 6 mg deucravacitinib tablets manufactured by Sun Pharmaceutical Industries Limited compared to SOTYKTU. Establishing bioequivalence is clinically essential to ensure that the test product demonstrates a comparable rate and extent of absorption to the reference product. This study is conducted in healthy adult subjects under fasting conditions. Trial scope: 8.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, within the age range of 18 to 30 years. This cohort is classified as a vulnerable population. There is no data provided concerning medical conditions such as plaque psoriasis, lifestyle considerations, or specific selection processes.

This open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study is designed to compare Deucravacitinib 6 mg tablets manufactured by Sun Pharmaceutical Industries Limited with SOTYKTU 6 mg tablets. The investigation will be conducted in healthy, adult, human subjects under fasting conditions. The research methodology involves a sequence of study visits, beginning with a screening visit to assess eligibility. Following administration, subjects will undergo specific follow-up visits to monitor pharmacological parameters before the end-of-study visit. The overall duration of the trial is estimated to span from February 2026 to May 2026. Participation may be subject to early termination based on predefined clinical criteria or protocol deviations.

Efficacy assessment in this Phase 2 clinical trial for plaque psoriasis is not specified in the provided documentation.