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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2013, Vol. 18 ›› Issue (4): 371-375.

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Consistency assessment and disposition in vivo after oral administration of celecoxib capsules to Beagle dogs

CUI Tao1,2, GAO Jing2, YI Xiu-lin2, ZENG Yong2, LI Wei2, SI Duan-yun2   

  1. 1 Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;
    2 State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China
  • Received:2012-10-19 Online:2013-04-26 Published:2013-04-26

Abstract: AIM: Establish an HPLC method for the determination of celecoxib in dog plasma. Besides evaluate in vivo disposition consistency by comparing their pharmacokinetic parameters after oral administration of celecoxib capsules or Celebrex to Beagle dogs.METHODS: According to a two-period crossover design, 8 Beagle dogs received a single oral dose of test or reference capsules, respectively. The plasma concentration of celecoxib was determined by the established HPLC method. The pharmacokinetic parameters and relative bioavailability were calculated.RESULTS: The relative bioavailability of celecoxib was (106.0±26.7) %. Based on the analysis of variance, two-sided t-test and rank sum test of the pharmacokinetic parameters including tmax, Cmax, and AUC(0→t), there were no significant difference between both preparations (P>0.05).CONCLUSION: The disposition in vivo of celecoxib capsules is in consistency with that of Celebrex.

Key words: Celecoxib, Bioavailability, High performance liquid chromatography

CLC Number: