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Bioequivalence study of domestic made cefpodoxime proxetil capsules in healthy volunteers

Article Review

   by:TsingHua    
Original Author: Chinese Journal of Infection and Chemotherapy
This abstract was translated from 国产头孢泊肟酯胶囊人体生物等效性研究
Objective: A bioequivalence study of domestic made cefpodoxime proxetil capsules was done and compared with imported cefpodoxime proxetil tablets in 20 healthy volunteers. Methods: A single oral 200?mg domestic made capsule and imported 200?mg cefpodoxime proxetil tablet were given to healthy volunteers according to a randomized 2 way cross over design. Blood samples were taken for the detection of serum concentration of cefpodoxime proxetil by high pressure liquid chromatography method. Pharmacokinetic parameters were analyzed using 3P97. Results: The mean peak concentration ( c max ) of domestic capsule group and imported cefpodoxime proxetil tablet group were (3.52±0.79)mg /L and (3.75±0.68)mg /L respectively; the area under the concentration time curve (AUC) were (20.68±4.71)mg /(L·h) and (21.18±4.55) mg /(L·h),the mean peak time ( t max ) were (3.18±0.88)h and (3.05±0.63)h, the mean plasma elimination half life (t 1 /2β ) were (2.40±0.57)h and (2.02±0.47)h, respectively. Conclusion: Domestic made capsules and imported tablets of cefpodoxime proxetil are bioequivalent. The relative bioavailability of domestic cefpodoxime proxetil capsule compare with imported tablet is (98.15±12.58) %.
Published: April 28, 2003
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