Effects of Tablet Formulation, Food, or Gastric pH on the Bioavailability of Asundexian

• Published in: Clinical pharmacology in drug development Vol. 12; no. 2; pp. 219 - 230
• Main Authors: Kanefendt, Friederike, Brase, Christine, Unger, Sigrun, Kubitza, Dagmar
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.02.2023; John Wiley and Sons Inc
• Subjects: Antacids; anticoagulation; asundexian; BAY 2433334; Bioavailability; Biological Availability; factor XIa; Food; Humans; Hydrogen-Ion Concentration; Inhibitor drugs; Male; Original; pharmacokinetics; Ratios; Tablets; Therapeutic Equivalency; pharmacokinetics; BAY 2433334; bioavailability; asundexian; anticoagulation; factor XIa

ABSTRACT Absolute bioavailability (F) and the impact of gastric pH, tablet formulation, and food on the pharmacokinetics and safety of asundexian, an oral factor XIa inhibitor, was assessed in healthy White men aged 18–45 years in 4 studies. For F, fasted participants received 50 μg of [13C7,15N]‐la...