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Safety and pharmacokinetic comparison between fenofibric acid 135 mg capsule and 110 mg entericcoated tablet in healthy volunteers.

Safety and pharmacokinetic comparison between fenofibric acid 135 mg capsule and 110 mg entericcoated tablet in healthy volunteers.

Authors :
Yu-Bin Seo
Jae Hoon Kim
Ji Hye Song
WonTae Jung
Kyu-Yeol Nam
Nyung Kim
Youn-Woong Choi
SangMin Cho
Do-Hyung Ki
Hye Jung Lee
JungHa Moon
SeungSeob Lee
JaeHee Kim
Jang Hee Hong
Jung Sunwoo
Jin-Gyu Jung
Source :
Translational & Clinical Pharmacology; Jun2023, Vol. 31 Issue 2, p95-104, 10p
Publication Year :
2023

Abstract

This study aimed to compare the pharmacokinetic (PK) and safety profiles of 2 fenofibric acid formulations under fasting and fed conditions. The reference was a 135 mg capsule, while the test was a 110 mg enteric-coated tablet. This randomized, open-label, two-sequence, two-period crossover phase 1 clinical trial was conducted in healthy Korean men. Sixty participants were enrolled in each of the fasting and feeding groups. Blood samples were collected 72 hours after drug administration. PK parameters were calculated using a noncompartmental method with Phoenix WinNonlin®. A total of 53 and 51 participants from the fasting and feeding groups, respectively, completed the study. The geometric mean ratio and 90% confidence intervals of the maximum concentration (C<subscript>max</subscript>) and area under the concentration-time curve to the last measurable plasma concentration were 0.9195 (0.8795-0.9614) and 0.8630 (0.8472-0.8791) in the fasting study and 1.0926 (1.0102-1.1818) and 0.9998 (0.9675-1.0332) in the fed study, respectively. The time to reach C<subscript>max</subscript> of the enteric-coated tablet compared to that of the capsule was extended by 1 and 3 hours under fasting and fed conditions, respectively. In conclusion, enteric-coated tablets have a higher bioavailability than capsules. In addition, the enteric-coated tablet was smaller than the capsule, making it easier for patients to swallow. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
22890882
Volume :
31
Issue :
2
Database :
Complementary Index
Journal :
Translational & Clinical Pharmacology
Publication Type :
Academic Journal
Accession number :
164852440
Full Text :
https://doi.org/10.12793/tcp.2023.31.e7