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

Abstract

Fenofibrate is a serum lipid-modifying agent that is commonly used to treat dyslipidemia. This study aimed to compare the pharmacokinetics (PKs) and establish bioequivalence of two 145-mg fenofibrate formulations, AD-104 (test) and TRICOR® (reference). This randomized, open-label, two-sequence, two-period crossover study was conducted in healthy Korean participants. Forty participants were enrolled and received either the test or reference formulation during each period, with a 14-day washout between doses. Blood samples were collected pre-dose and up to 72 h post-dose. PK parameters were assessed using non-compartmental analysis with Phoenix WinNonlin®. Bioequivalence was determined if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of the maximum plasma concentration (C_max) and the area under the concentration-time curve from time zero to the last measurable plasma concentration (AUC_last) were within the bioequivalence limits of 0.80 to 1.25. Thirty-eight participants completed the study and were included in the PK analysis. The GMR and 90% CIs for the C_max and AUC_last of the test compared to the reference formulation were 0.8643 (0.8283-0.9019) and 0.9930 (0.9631-1.0239), respectively, both within the bioequivalence limits. No serious adverse events were reported during the study. This study demonstrates that the test formulation is bioequivalent to the reference formulation in healthy Korean participants. Both formulations were safe and well-tolerated; therefore, AD-104 is expected to benefit Korean patients with dyslipidemia. Clinical Research Information Service No. is as follows: KCT0009332 (April 12, 2024).