Comparative pharmacokinetics and bioequivalence of 145-mg fenofibrate formulations in healthy Korean participants

Fenofibrate is a widely used lipid-modifying agent for dyslipidemia, and this publication reports a bioequivalence study comparing a new 145-mg test formulation (AD-104) against the reference product TRICOR in 40 healthy Korean participants. Using a randomized, open-label, two-sequence, two-period crossover design with a 14-day washout, pharmacokinetic parameters were derived from plasma samples collected over 72 hours using non-compartmental analysis in Phoenix WinNonlin. The geometric mean ratios and 90% confidence intervals for Cmax and AUC0-t both fell within the standard 0.80-1.25 bioequivalence limits, and no serious adverse events were reported. The results demonstrate that the test formulation is bioequivalent and comparably well tolerated, supporting its potential use as an alternative treatment option for dyslipidemia in Korean patients.