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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2008, Vol. 13 ›› Issue (3): 315-319.

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Bioavailability and bioequvilence of bezafibrate capsule in human

XIAO Feng, WU Cheng-yi, TAO Chun-lei, GAN Lei, WEI Wei   

  1. Institute of Clinical Pharmacology of Anhui Medical University, Key Laboratory of Antiinflammatory and Immunopharmacology in Anhui Province, Anhui Engineering Research Center of Antiinflammatory and Immune Drugs, Hefei 230032, Anhui, China
  • Received:2008-02-29 Revised:2008-02-29 Published:2020-10-15

Abstract: AIM: To study the bioavailability and bioequvilence of bezafibrate capsule and tablet in health human. METHODS: 20 health volunteers were given bezafibrate capsules and tablets 400mg once with the interval of one week.Plasma samples were obtained and determined with HPLC method.Pharmacokinetics parameters were calculated and compared with DAS software. RESULTS: The main pharmacokinetics parameters of bezafibrate capsules and tablets were as follow:t1 2 (1.9 ±0.5) 、(2.0 ±0.6) h;Cmax (12±4) 、 (11±3) μg mL;tmax (1.7±0.9) 、(1.9±0.7) h; AUC(0-12) (36±10)、(33±7)μg·mL-1·h;AUC(0-∞) (37±10) 、(34±7) μg·mL-1 h.The biovailability of bezafibrate capsule campared to tablet was 92.3%and 92.9%. CONCLUSION: The test bezafibrate capsule is bioequivalent to the reference talbet in health human.

Key words: bezafibrate, bioavailability, HPLC, pharmacokinetics

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