Bioequivalence evaluation of two brands of aceclofenac 100mg tablets (Aceclofar and Bristaflam) in healthy human volunteers

A randomized, two‐way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of aceclofenac 100mg tablets, Aceclofar (Julphar, UAE) as test and Bristaflam (Bristol Myers Squibb, Egypt) as the reference product. The drug was administered with 240ml of water after a 10h overnight fast on two treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 24h. Plasma harvested from blood was analysed for aceclofenac by a validated HPLC method with UV‐visible detection capable of detecting aceclofenac in the range 0.2–8.0μg/ml with the limit of quantitation as 0.2μg/ml. Various pharmacokinetic parameters including AUC0−t, AUC0−∞, Cmax, Tmax, T1/2, and λZ were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC0−t, AUC0−∞, and Cmax were tested for bioequivalence after log‐transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (100.0%–106.4% for AUC0−t, 100.2%–106.8% for AUC0−∞; 83.3%–102.8% for Cmax) of test/reference ratio for these parameters were found to be within the bioequivalence acceptance range of 80%–125%. Based on these statistical inferences, it was concluded that Aceclofar is bioequivalent to Bristaflam. Copyright © 2004 John Wiley & Sons, Ltd.