Pharmacokinetics and bioequivalence of two fenofibrate choline formulations in healthy subjects under fed and fasted condition

Ji Min Park, Soo In Chae, Young Su Noh, Seung Jun Lee, Wang Seob Shim, Ji Min Yoon, Se Jung Hwang, Kyung Tae Lee, Eun Kyoung Chung

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Objective: The objective of this study was to evaluate the pharmacokinetics and bioequivalence of two formulations (the original capsule (“reference”) and the new tablet (“test”) formulations) of 135-mg choline fenofibrate under fed and fasted conditions. Materials and methods: This was an open-label, randomized, single-dose, crossover bioequivalence study in healthy Korean males. A total of 40 individuals were separately enrolled in the high-fat fed and the fasting study, respectively, and were randomized in a 1:1 ratio into two sequences. Serial blood samples were collected over 72 hours after drug administration. Plasma concentrations of fenofibric acid were determined by a validated LC-MS/MS method. Pharmacokinetic (PK) parameters were estimated using noncompartmental methods. Results: Overall, 37 and 35 individuals completed the fed and the fasting study, respectively, as planned. The estimated Cmax, AUC0–∞, and AUC0–last were comparable between the test and the reference formulations in both fed and fasting studies (p > 0.05). The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0–∞, and AUC0–last were 0.92 – 1.06, 0.95 – 1.01, and 0.95 – 1.01 in the fed study; and 0.94 – 1.12, 0.94 – 1.00, and 0.94 – 1.00 in the fasting study, respectively. For both formulations, tmax was significantly prolonged under fed condition compared to fasting condition (p < 0.0001); all other PK parameters were comparable between the fed and the fasting studies (p > 0.05). Conclusion: The reference and the test formulations of 135 mg choline fenofibrate show comparable pharmacokinetic profiles of fenofibric acid under both fed and fasted conditions and are considered bioequivalent.

Original languageEnglish
Pages (from-to)217-228
Number of pages12
JournalInternational Journal of Clinical Pharmacology and Therapeutics
Volume57
Issue number4
DOIs
Publication statusPublished - 2019

Bibliographical note

Publisher Copyright:
©2019 Dustri-Verlag Dr. K. Feistle

Keywords

  • Bioequivalence
  • Dyslipidemia
  • Fenofibrate
  • Pharmacokinetics

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