A randomized, open-label, single-dose study to evaluate the safety and pharmacokinetics of two formulations containing 40 mg of fexuprazan in healthy Korean subjects

Resultado clave

The 40-mg fexuprazan tablet A is bioequivalent to tablet B with comparable AUC and Cmax, both well tolerated without meaningful safety differences.

Puntos clave

• To assess the safety and pharmacokinetics of two 40 mg fexuprazan formulations in a healthy population.
• Randomized, open-label, single-dose study design
• Comparison of two formulations (tablet A and tablet B)
• Pharmacokinetic measurements including AUC and Cmax
• Evaluation of adverse events profiles
• Both formulations showed bioequivalence with comparable AUC values
• Peak concentration (Cmax) was similar for both tablets
• No significant differences in adverse events noted
• Both formulations were well tolerated by participants.