Title: Bioequivalence of cloxacillin tablets and capsules in healthy volunteers
Abstract: AIM To evaluate the bioequivalence of the tablets (test preparation) and capsules(reference preparation) of cloxacillin in human body.METHODS A randomized two-period crossover study of 20 healthy male volunteers was taken with two kinds of 500 mg cloxacillin formulation already mentioned orally for each individual and their blood concentrations in vivo were conducted.The main pharmacokinetic parameters (AUC, c_(max) and t_(max)) and bioequivalence effects were evaluated using 3P97 software program.RESULTS The main pharmacokinetic parameters of the tested and referenced groups including t_(1/2),c_(max),AUC_(0-t),AUC_(0-∞)were (1.3±s 0.3) vs (1.21±0.26) h;(14±4) vs (15±4) mg·L~(-1);(23±5) vs (24±6) mg·h·L~(-1);(23±5) vs (25±6) mg·h·L~(-1),respectively,showing no significant differences between the two groups by analysis variance and two one-side t-tests.The relative bioavailability of the tested group was (98±27)%.CONCLUSION The cloxacillin tablets and capsules are bioequivalent.
Publication Year: 2008
Publication Date: 2008-01-01
Language: en
Type: article
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