Comparative Bioequivalence of Tablet and Capsule Formulations of Ulotaront and the Effect of Food on the Pharmacokinetics of the Tablet Form in Humans

Ulotaront is a dual trace amine-associated receptor 1 and 5-HT1A receptor agonist in Phase 3 development for schizophrenia. This publication reports two crossover studies in healthy volunteers: one comparing the bioequivalence of tablet and capsule ulotaront formulations, and another assessing the food effect on the tablet formulation's pharmacokinetics, with parameters calculated using Phoenix WinNonlin. Geometric mean ratios and 90% confidence intervals for Cmax and AUC fell well within standard bioequivalence criteria for both the formulation comparison and the food-effect study, though a delay in time to peak concentration was observed under fed conditions. The results confirm bioequivalence between ulotaront tablet and capsule formulations and indicate no clinically significant food effect on tablet pharmacokinetics.