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
Abstract
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
22 subjects completed the study and were included in the pharmacokinetic analysis. Geometric mean values of area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUCt) was 380.17 and 390.33 ng×h/mL for the test and reference formulations, respectively. Geometric mean values of maximum plasma concentration (Cmax) were 29.36 and 31.65 ng/mL for the test and reference formulations, respectively. The 90% confidence intervals (CIs) for the test/reference geometric mean ratios of AUCt and Cmax were 0.9098 - 1.0427 and 0.8665 - 0.9931, respectively. All adverse events were mild, and no serious adverse events occurred.
CONCLUSION
The novel 40-mg fexuprazan formulation (tablet A) was demonstrated to be bioequivalent to the initially developed…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 24 participants or records.
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