Study of pharmacokinetics and bioavailability of two dexibuprofen formulations in healthy volunteers

OBJECTIVE：To study the pharmacokinetics and bioavailability of two dexibuprofen formulations in 20 healthy volunteers.METHODS：A single oral dose containing 300mg dexibuprofen was given to 20 volunteers in randomized crossover study.Concentrations of dexibuprofen in plasma were determined by HPLC.The plasma concentration-time curves of two products were all fitted to a two-compartment model. RESULTS：The pharmacokinetic parameters of capsuls formulation were: T 1/2(2.0±0.7)h, T max(1.7±1.0)h; C max(26.4±5.3)μg·ml-1; CL / F (3.5±0.8)L·h-1; Vd / F (8.0±2.0)L,(8.0±1.7)L； AUC (89.2±19.1)μg·L-1·h. Relative bioavailability was(98.9±10.1)%.CONCLUSIONS：The results of two one-sided tests statistical analysis and rank sum test showed that two formulations were bioequivalent.