Summary
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 μg/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 1 and the AUG∞ was 86.9±24.6 μgh/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 μg/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 1 and the AUC∞ was 52.4±11.3 μgh/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.
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Farré, A.J., Colombo, M., Fort, M., Gutierrez, B. Rodríguez, L., Roser, R. (1986): Pharmacological properties of droxicam, a new non-steroidal antiinflammatory agent. Meth. Find. Exptl. Clin. Pharmacol., 8, 407–422.
Esteve, J., Martínez, L., Roser, R., Sagarra, R. (1987): Effects of droxicam on in vivo prostaglandin synthesis and ex vivo platelet aggregation. Meth. Find. Exptl. Clin. Pharmacol., 9, 209–213.
Palacios, G., Castell, O., Colombo, M., Roser, R. Esteve, J., (1987): Comparative light and electron microscopic observations of the lesive effects of two non-steroid anti-inflammatory drugs plus stress on rat gastric mucosa. Meth. Find. Exptl. Clin. Pharmacol., 9, 353–370.
Esteve, J., Farré, A.J., Roser, R. (1988): Pharmacological profile of droxicam. Gen. Pharmacol., 19, 49–54.
Frigola, J. (1988): Study of the structure of droxicam, 5-methyl-3-(2-pyridyl)-2H,5H-1,3-oxazino [5,6-c][l,2]-benzothiazine-2,4-(3H)-dione 6,6-dioxide, using X-ray crystallography and 1H and 13C nuclear magnetic resonance spectroscopy. J. Chem. Soc. Perkin Trans., 241–245.
Esteve, A., Martínez, L., Roser, R., Sagarra, R. (1986): Pharmacokinetics of droxicam in rat and dog. Meth. Find. Exptl. Clin. Pharmacol., 8, 423–429.
Martínez, L., Sánchez, J., Roser, R., et al. (1988): Comparative study of the multiple dose pharmacokinetics and the tolerance of a new NSAID (droxicam) versus piroxicam in healthy volunteers. Meth. Find. Exptl. Clin. Pharmacol., 10, 729–737.
Sánchez, J., Martínez, L., García-Barbal, J., Roser, R., Bartlett, A., Sagarra, R. (1989): The influence of gastric emptying on droxicam pharmacokinetics. J. Clin. Pharmacol., 29, 739–745
Wolfe, S. (1986): Safety of piroxicam. Lancet, 808–809.
Twomey, T., Bartolucci, S., Hobbs, D. (1980): Analysis of piroxicam in plasma by high-performance liquid chromatography. J. Chromatogr., 183, 104–108.
Hobbs, D., Twomey, T. (1979): Piroxicam pharmacokinetics in man: aspirin and antacid interaction studies. J. Clin. Pharmacol., 19, 270–281.
Ishizaki, T., Nomura, T., Abe, T. (1979): Pharmacokinetics of piroxicam, a new nonsteroidal anti-inflammatory agent, under fasting and postprandial states in man. J. Pharmacokinet. Biopharm., 7, 369–381.
Siegmeth, W. (1980) Relationship between the serum concentrations of piroxicam and its clinical afficacy in patients with rheumatoid arthritis. Wien. Med. Wochenschr., 130/spec. Iss., 31–36
Fourtillan, J., Dubourg, D. (1983): Etude pharmacocinétique du piroxicam chez l’homme sain, après administration d’une dose unique égale à 20 mg par voie orale. Thérapie, 38, 163–170.
Fraser, A., Woodbury, J. (1983): Liquid chromatographic determination of piroxicam in serum. Ther. Drug Monitor, 5, 239–242.
Brogden, R.N., Heel, R.C., Speight, T.M., Avery, G.S. (1981): Piroxicam: a review of its pharmacological properties and therapeutic efficacy. Drugs, 22, 165–187.
Richardson, C., Blocka, K., Ross, S., Verbeeck, R. (1985): Effects of age and sex on piroxicam disposition. Clin. Pharmacol. Ther., 37, 13–18.
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Martinez, L., Sanchez, J., Roser, R. et al. Single and multiple dose pharmacokinetics of a new NSAID (droxicam) in healthy volunteers. Eur. J. Drug Metab. Pharmacokinet. 14, 303–307 (1989). https://doi.org/10.1007/BF03190116
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DOI: https://doi.org/10.1007/BF03190116