A bioequivalence study of oral Vonoprazan in healthy male subjects under fasting conditions

Objectives: The aim of this study was to evaluate the bioequivalence (BE) of two oral tablet formulations of Vonoprazan (VNP) 20 mg in 30 healthy male subjects under fasting conditions. Materials and Methods: This study was a randomized, open-label, balanced, two-period, two-sequence, single oral dose, and crossover study. Thirty (30) healthy subjects were assigned to one of two sequences protocol: INZELM® 20 mg, as reference product (R) sequence R-T or VNP 20 mg as test product (T) sequence T-R to period I and vice versa to period II, with a washout period between the two periods. Pharmacokinetic (PK) parameters in plasma concentrations were determined using a validated Liquid Chromatography-Mass Spectrometry (LC-MS/MS) method. Results: The results showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of C max : 100.79% (94.55–107.44%), area under the curve (AUC) 0-t : 97.42% (92.72–102.35%), and AUC 0-inf : 97.35% (92.52–102.43%) were within the BE (80–125%) acceptance range. Conclusion: The PK profiles of INZELM® VNP 20 mg (Takeda Pharmaceutical Company Limited) as reference (R) product and VNP 20 mg (Laboratorios Leti, S.A.V) as test (T) product were bioequivalent. No adverse events were reported.