Bioequivalence of two brands of piroxicam 20 mg capsule in healthy human volunteers

ABSTRACT

An open randomized, two-way crossover study was carried in 12 healthy volunteers. The two commercial brands used were Uphaxicam [Upha, Malaysia] as test and Feldene [Pfizer, France] as reference product. The drug was administered to each subject with 240 ml of water after an overnight fasting in two treatment days separated by three weeks washout period. The bioavailability was compared using the parameters total area under the plasma concentration time curve [AUC [0-infinity]], peak plasma concentration [C max] and time to reach maximum plasma concentration [T max]. No statistically significant difference was observed between the values of two products in AUC [0-infinity] and C max while significant difference was found in T max However, the 90% confidence interval for the ratio of logarithmic-transformed AUC[0-infinity] and C max values of Uphaxicam over those of Feldene was found to lie between 0.92- 1.03 and 0.91-1.00, respectively, being within the acceptable bioequivalence limit of 0.8-1.25. Based on this data, it is concluded that both formulations are bioequivalent and interchangeable in medical practice