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Shvoong Home>Medicine & Health>Relative bioequivalence and pharmacokinetics of Cefixime capsules in healthy volunteers Review

Relative bioequivalence and pharmacokinetics of Cefixime capsules in healthy volunteers

Article Review   by:TsingHua     Original Author: Journal of The Fourth Military Medical University
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AIM: To compare the pharmacokinetic parameters and relative bioavailability of domestic and imported Cefixime capsules in healthy volunteers and to study the quality of the medicine. METHODS: A single oral dose of 200mg domestic and imported Cefixime capsules was given to 12 healthy volunteers in a randomized two period crossover study. The concentrations of Cefixime in serum were determined by HPLC method. The main pharmacokinetics parameters (AUC, ρ max and T max ) were analyzed by two simultaneous one sided t test. RESULTS: The concentration time curves of domestic and imported Cefixime capsules conformed to the one compartment open model with first order absorption. The AUC (0~24 h), ρmax and Tmax of domestic and imported Cefixime capsules were (25.88±3.75 )and ( 24.67 ±4.30)mg·h -1 ·L -1 ,(2.97±0.54)and(2.83±0.55)mg·L -1 , and (3.39±0.50)and (3.33 ±0.48)h respectively. The relative bioavailability of domestic Cefixime capsules was 104.9%. CONCLUSION: Both domestic and imported Cefixime capsules are of the same bioequivalence in healthy volunteers.
Published: April 15, 2003   
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