Investigation of bioequivalence of thiamphenicol capsules in healthy volunteers

AIM:To study the bioequivalence of thiamphenicol capsules in healthy volunteers . METHODS:Twenty volunteers were randomly divided into 2 groups,ten f or each and undertaken two crossover designs. Blood samples were collected at 0, 0.5,1,1.5,2,3,4,6,8,12,24,36,48,72 h after a single oral dose of 500 mg thiamphenicol capsules of test or reference respectively. The time-concentr a tions of thiamphenicol were determined by HPLC and pharmarcokinetic parameters calculating with DAS practical pharmacokinetic programme. RESULTS: The pharmarcokinetic pa rameters of thiamphenicol capsules of test and reference were as follows: t _(1/2)(3.7±s 0.5) h and ((3.1±)0.6) h ,t_(max) (2.0±( 0. 3) h) and ( 2.0±0.3) h,c_(max) (2.3±0.6) mg·L~(-1) and (2.3±0.5) mg·L~(-1),AUC_(0-12)(9.0±1.4) mg· h·L~(-1) and (9.0±(1.6) mg·h·L~(-1),)AUC_(0-∞) (9.8±1 .8) mg·h·L~(-1) and (9.8±1.6) mg·h·L~(-1), respectively. The relativ e bioavailability of thiamphenicol capsules was (101±6) %. CONCLUSION: The statistical analysis showes that thiamphenicol capsules of the test and ref er ence are bioquivalent.