A 2-Part, Open-Label, Phase 1 Bioequivalence and Food-Effect Study of Ubrogepant in Healthy Adult Participants.

ABSTRACT: This Phase 1 study of ubrogepant was conducted to establish the bioequivalence (BE) of the 50- and 100-mg to-be-marketed (TBM) tablet formulations with the clinical trial (CT) 100-mg tablet formulation and evaluate the food effect on the bioavailability of the 100-mg TBM tablet. This 2-part study enrolled healthy participants aged 18-45 years. Part A assessed BE following a single dose of TBM versus CT tablets. Part B evaluated the impact of a high-fat meal on ubrogepant pharmacokinetics. Safety and tolerability were assessed along with standard pharmacokinetic parameters. In Part A (n  =   47), the geometric mean ratio and 90% confidence intervals for maximum plasma drug concentration, area under the plasma concentration-time curve (AUC) from time zero to time t, and AUC from time zero to

SUBMITTER: Boinpally R 

PROVIDER: S-EPMC12209997 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature