Bioequivalence of ampiroxicam capsules in healthy volunteers

Objective: To determine the concentration of piroxicam,the metabolin of ampiroxicam,for assessment of bioequivalence of ampiroxicam capsules in Chinese healthy volunteers.Methods:20 healthy volunteers were divided into 2 groups and administrated a single dose of test ampiroxicam capsules or reference ampiroxicam tablets(27mg),respectively.The concentration of piroxicam in human plasma was determined by HPLC-UV collected on various times after administration.The pharmacokinetic parameters were calculated by DAS 2.1 software as well as variation analyses and two one-side t-test.Results:The main pharmacokinetic parameters of test and reference formulation were as follows:t1/2 were(49.19±11.50)and(47.85±9.86)h,Cmax were1(1.885±0.361)and(1.90±0.40)mg/L,Tmax were(7.21±3.34)and(6.95±3.33)h,AUC0-216 were(155.02±36.60) and(150.23±31.371)mg/L·h,AUC0-∞ were(164.52±41.20)and(159.00±33.77)mg/L·h.Conclusion:The relative bioavailability of ampiroxicam capsules was(103.9±17.0)%.The ampiroxicam capsules and tablets are bioequivalent.