Key result
Novel 40-mg fexuprazan tablet A demonstrates bioequivalence and comparable safety to tablet B.
Why the study?
Is the novel 40-mg fexuprazan formulation bioequivalent to the initially developed formulation in healthy Korean subjects?
Is the novel 40-mg fexuprazan formulation bioequivalent to the initially developed formulation in healthy Korean subjects?
A novel 40-mg fexuprazan formulation is bioequivalent and has a comparable safety profile to the original formulation in healthy Korean subjects.
Clinicians may prescribe novel fexuprazan tablet interchangeably; confirms bioequivalence and safety, extending formulation options.
OBJECTIVE: To evaluate the pharmacokinetics and safety of two 40-mg fexuprazan formulations. MATERIALS AND METHODS: This study was an open-label, randomized, single-dose, crossover bioequivalence trial in healthy subjects. 24 subjects were randomized to receive either the test formulation, tablet A (40 mg fexuprazan), or the reference formulation, tablet B (40 mg fexuprazan), with crossover administration. Plasma samples were collected up to 48 hours post-dose and analysed for fexuprazan using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). Individual pharmacokinetic parameters were derived by noncompartmental analysis. Safety was evaluated throughout the study. RESULTS: were 0.9098 - 1.0427 and 0.8665 - 0.9931, respectively. All adverse events were mild, and no serious adverse events occurred. CONCLUSION: ). Both formulations were well tolerated, with no clinically meaningful differences in adverse event profiles.
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Hur et al. (2026) studied this question. The 40-mg fexuprazan tablet A is bioequivalent to tablet B with comparable AUC and Cmax, both well tolerated without meaningful safety differences.
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