Relative Bioavailability of Ibuprofen Sustained Release Capsules in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of ibuprofen sustained release capsules in healthy volunteers for evaluating the bioequi valency .METHODS: 20 healthy volunteers took a single dose(600mg) of ibuprofen sustained release capsules and fenbid capsules(as reference drug) alternatively, then the plasma concentrations of ibuprofen were determined by HPLC.The pharmacokinetic parameters were calculated with 3p87 pharmacokinetic program and the bioequivalence was calculated .RESULTS: The pharmacokinetic parameters of ibuprofen sustained release capsule and fenbid capsule wereT1/2= (2.88+ 0.25)h, (2.91 + 0.33)h;Cmax = (30.66+ 4.21)mg/L, (29.09+3.54)mg/L;Tmax = (4.4 + 0.52)h, (4.3+0.48)h;AUCo-1, = (174.26+13.95)mg/(h . L), (165.80+ 11.89)mg/(h ?L) ;C = (16.25+ 1.47)mg/L, (15.63+1.83) mg/L; Cmin= (1.36 + 0.56) mg/L, (1.24 + 0.46) mg/ L; FI = (1.83 + 0.07), (1.84 + 0.06) .The relative bioavailability of ibuprofen sustained release capsule was( 105.10 + 7.77) % .CONCLUSION: Ibuprofen sustained release capsule and fenbid (reference drug) were bioequivalent.