Bioequivalence of two aceclofenac tablet formulations after a single oral dose to healthy male Korean volunteers.

A bioequivalence study of aceclofenac tablets (test formulation: Dong-A, reference formulation: Airtal) was conducted in 16 healthy male Korean volunteers who received each medicine at a dose of 100 mg in a 2 x 2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of aceclofenac were monitored by high-performance liquid chromatography over a period of 24 hours after the administration. AUC inf (the area under the plasma concentration-time curve from time zero to time infinity) was calculated by the linear-log trapezoidal method. C max (maximum plasma drug concentration) and t max (time to reach C max ) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC inf and C max , and non-transformed t max . There were no significant differences between the medications in AUC inf and C max . The point estimates and 90% confidence intervals for AUC inf (parametric) and C max (parametric) were 1.04 (0.93 ∼ 1.17) and 0.99 (0.91 ∼ 1.08), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. The corresponding value for t max was 0.75 (0.00 ∼ 1.00), Moreover, the modified Pitman-Morgan's adjusted F-test indicated that the bioavailabilities of aceclofenac in the 2 medications were comparable regarding intra- and interindividual variability. Therefore, these results indicate that the 2 medications of aceclofenac are bioequivalent and, thus, may be prescribed interchangeably.