Effect of Food on Pharmacokinetics and Pharmacodynamics of Fenofibric Acid after a Single Oral Dose of Fenofibrate Sustained-Release Capsule

식단에 따르는 페노피브레이트 서방성 캡슐의 1회 경구 투여 후 약물동태학 및 약물동력학의 평가

  • 윤휘열 (충남대학교 약학대학 임상약학 연구실) ;
  • 김정현 (충남대학교 약학대학 임상약학 연구실) ;
  • 이은주 (충남대학교 약학대학 임상약학 연구실) ;
  • 정수연 (충남대학교 약학대학 임상약학 연구실) ;
  • 최선옥 (식품의약품 안전청 생물측정과) ;
  • 김형기 (식품의약품 안전청 생물측정과) ;
  • 권준택 (순천향 대학교 의과대학 임상약리학 실험실) ;
  • 강원구 (한국 화학 연구소 부설 안전성 평가 연구소) ;
  • 권광일 (충남대학교 약학대학 임상약학 연구실)
  • Published : 2005.06.01

Abstract

We examined the effects of food on pharmacokinetic and pharmacodynamic properties of fenofibrate released from sustained-release(SR) capsule as therapy for hypolipidemia. Twenty-four healthy volunteers were used in $3{\times}3$ crossover pharmacokinetic and pharmacodynamic study; Additional six volunteers were used as a control group (i.e., no fenofibrate administration). A single dose of fenofibrate (SR capsule, 250 mg) was administered on three occasions: after overnight fasting, after consumption of a standard breakfast, and after a high-fat breakfast. Serial blood samples were collected for the next 72 hours. Plasma fenofibric acid concentrations were measured by high performance liquid chromatography, and pharmacokinetic parameters were calculated using ADAPT II program. Plsama triglyceride concentrations were measured by blood chemistry analyzer (CH-100). The pharmacokinetic parameters were significantly affected by food intake. The high-fat breakfast affected the rate of absorption of fenofibrate more than did the standard breakfast and fasted conditions. Plasma concentrations of triglyceride at 24 hours decreased significantly after the administration of fenofibrate compared with the concentration at 0 hours(P<0.05). In healthy volunteers, the bioavailability of fenofibrate was greater when administered via sustained-release capsules immediately after the consumption of food than after fasting condition.

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