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 concentrat

SUBMITTER: Lee S 

PROVIDER: S-EPMC12511228 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature