A Comparative Pharmacokinetic Study of Fexuprazan 10 mg: Demonstrating Bioequivalence with the Reference Formulation and Evaluating Steady State

Fexuprazan is a potassium-competitive acid blocker approved for treating gastric-acid-related diseases. Although the effectiveness of recent formulation fexuprazan 10 mg has been demonstrated in Phase 3 clinical trials, data on pharmacokinetics (PKs) administering twice daily at 12 h interval are lacking. Moreover, it imperative to ensure bioequivalence new with previously 40 formulation. This study evaluated single- and multiple-dose oral administration tablets healthy participants (Part 1) investigated their 2). Part 1 comprised multiple-dose, one-sequence, two-period design eight participants, while 2 single-dose, × crossover 24 participants. In 1, Periods 2, received single multiple doses (twice daily) mg, respectively. The maximum plasma concentration (Cmax) area under concentration–time curve from 0 (AUC0–12h) was approximately double that single-dose geometric mean ratios (90% confidence intervals) Cmax AUC zero time last quantifiable (AUClast) use four those one tablet were 1.0290 (0.9352–1.1321) (0.9476–1.1174), respectively, meeting criteria. Favorable PKs observed after administrations tablet, pharmacokinetically equivalent tablet.