A comparative bioavailability study to estimate the influence of an antacid on droxicam pharmacokinetics.

ABSTRACT

The influence of an antacid on droxicam pharmacokinetics was investigated in 12 healthy male volunteers. A two way cross-over study was performed after the oral administration of 20 mg of droxicam (Ombolan capsules) and droxicam together with an antacid (Mucal powder). The plasma concentrations of piroxicam, the active moiety of droxicam, were determined by a high-performance liquid chromatographic method. The pharmacokinetic parameter values (mean +/- RSD) of piroxicam after administration of droxicam alone were AUC0-->infinity = 125.5 +/- 25.1 micrograms.h/l, Cmax = 2.08 +/- 19.9 micrograms/l, tmax = 7.08 +/- 36.8 h and t1/2 = 46.3 +/- 27.0 h. Following administration of droxicam together with the antacid the values obtained for the same parameters were AUC0-->infinity = 135.1 +/- 24.1 micrograms.h/l. Cmax = 1.85 +/- 23.9 micrograms/l, tmax = 8.17 +/- 34.9 h and t1/2 = 52.0 +/- 22.4 h. These results indicate that concurrent administration of the antacid does not significantly change the bioavailability and pharmacokinetics of droxicam.