A Randomized, Open-Label, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Deucravacitinib 6 mg Tablets in Healthy Adult Subjects Under Fed 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 the reference product SOTYKTU under fed conditions. Establishing bioequivalence is essential to ensure that the generic formulation achieves comparable pharmacokinetic profiles to the branded medication for the treatment of plaque psoriasis.

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. The cohort includes vulnerable populations. No data was provided regarding plaque psoriasis or specific lifestyle considerations.

This open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study is designed to compare 6 mg Deucravacitinib tablets manufactured by Sun Pharmaceutical Industries Limited with 6 mg SOTYKTU tablets under fed conditions. The study will be conducted in healthy adult human subjects. The methodology involves a sequential administration of both treatments to allow for comparative analysis. The study procedures consist of a screening visit, treatment periods, and an end-of-study visit. The total duration of participant involvement is determined by the crossover design requirements. Early termination from the study may occur based on predefined protocol criteria.

The efficacy assessment in this Phase 2 clinical trial focuses on the therapeutic impact on plaque psoriasis.