A comparative bioavailability study of aceclofenac products in healthy human subjects

Abstract

This study was conducted to compare the bioavailability of two branded formulations of aceclofenac and to evaluate their pharmacokinetic behavior. For bioequivalence study of two formulations of aceclofenac; drug A and drug B were administered to 18 healthy human volunteers using a two-treatment, two-way cross over study design in a randomized fashion. For the determination of aceclofenac plasma concentration, validated HPLC method with UV-visible detector, 20 µl injecting loop and C18 analytical column were used. The lower limit of detection is 0.0195µg/ml and quantitation range is 0.039, 0.078, 0.156, 0.312, 0.625, 1.25, 2.5, 5, 10 and 20µg/ml. Different pharmacokinetic parameter were determined including Tmax, T1/2, Cmax, AUC0-t, AUC0-?, vd, ke for two formulations of aceclofenac in plasma. After log-transformation of plasma data for bioequivalence Cmax, AUC0-t and AUCt-? were tested. The Cmax values of 7.69 ± 0.14221µg/ml and 6.82 ± 0.13411µg/ml were attained in 3.14 ± 0.0801 h and 2.94 ± 0.1878 h for drug A and Drug B, respectively. AUC0-t was 45332.79 ± 2096.770µg.h/ml and 43842.56 ± 1046.954µg.h/ml, respectively. AUC0-? was 45329.97±2138.871µg.h/ml and 43589.97 ± 1039.78 µg.h/ml for drug A and Drug B, respectively. The t1/2 values were found to be 3.14 ± 0.080 h and 3.01 ± 0.024 h for drug A and Drug B.