Pharmacokinetics and Bioequivalance of Ibuprofen Tablet in Healthy Volunteers

Objective To investigate pharmacokinetic of Ibuprofen and to evaluate the bioequivalance.Methods Eighteen healthy male volunteers were enrolled into the single crossover study.After a single dose of the suspension equivalent to 400 mg Ibuprofen or a reference preparation were given by crossover.To develop a sensitive and specific HPLC-UV method for the determination of Ibuprofen in human plasma.The bioequivalence of the suspension and reference were evaluated by pharmacokinetic parameters and relative bioavailability obtained.Results The main pharmacokinetic parameters of test and reference Ibuprofen were as the followings:AUC 0-10 was(125.40±20.74)μg/(mL·h)and(130.38±24.79)μg/(mL·h);C max was(34.60±7.12)μg/mL and(37.88±7.13)μg/mL;T max was(2.0±0.5)h and(1.7±0.5)h;t 1/2 was(2.1±0.21)h and(2.19±0.29)h.The relative bioavailability of test to reference preparation was(98.2±18.7)%.Conclusion The two preparations are bioequivalent.