Single and multiple dose pharmacokinetics of a new NSAID (droxicam) in healthy volunteers.

Abstract

The pharmacokinetics of droxicam, both as a single 10 mg dose and as a multidose regimen of 10 mg/day for 20 consecutive days, have been studied in healthy volunteers. The study was performed in two separate groups of volunteers. Following a single dose the Cmax was 0.82 +/- 0.15 micrograms/ml, the Tmax was achieved at 6.1 +/- 3.5 h, the elimination half life was 65.7 +/- 17.6 h, the Clt/F was 2.04 +/- 0.53 ml/min, the Vd/F was 11.0 +/- 1.7 l and the AUC infinity was 86.9 +/- 24.6 mugh/ml, which was similar to results reported in other study from piroxicam (10 mg). Following multiple doses the Cmed(ss) was 2.06 +/- 0.42 microgram/ml, the Tmax(ss) was 8.2 +/- 6.0 h, the elimination half life was 41.4 +/- 12.4 h, the Clt/F was 3.30 +/- 0.63 ml/min, the Vd/F was 11.8 +/- 4.3 l and the AUC infinity was 52.4 +/- 11.3 mugh/ml. The differences encountered between single and multiple dose administration in elimination kinetics are due to the wide interpersonal variation described for the elimination half life of piroxicam. It may be concluded from these results that absorption, elimination and bioavailability kinetics of droxicam are independent of the administered dose.