singledose and multipledose pharmacokinetics and dose proportionality of intravenous and intramuscular hpcddiclofenac dyloject compared with other diclofenac formulations study objective to evaluate single and repeateddose pharmacokinetics pk and dose proportionality of hydroxypropylcyclodextrin hpcddiclofenac compared with voltarol after intravenous iv and intramuscular im administrationdesign study 1 singledose randomized fourway crossover study study 2 multipledose randomized threeway crossover studysetting clinical research centersubjects healthy adult volunteersintervention study 1 subjects received hpcddiclofenac and voltarol iv and im with a 5day washout between treatment periods study 2 subjects received two doses of iv hpcddiclofenac and oral cataflam once every 6 hours for four doses with a 48hour washout period between treatment periodsmeasurements and main results study 1 iv hpcddiclofenac had a higher peak plasma concentration cmax and earlier time to reach maximum plasma concentration tmax but equivalent plasma exposure area under the curve from time zero to t auc0t to iv voltarol the geometric mean ratio of hpcddiclofenac iv to voltarol iv for auc0t was 10627 the geometric mean ratio of hpcddiclofenac im to voltarol im for auc0t was 11091 the geometric mean ratio of hpcddiclofenac iv to hpcddiclofenac im for auc0t was 10125 the geometric mean ratio of hpcddiclofenac im to voltarol iv for auc0t was 10496 study 2 cmax for diclofenac was 2904 and 6031 ngml after the first iv dose of 1875 and 375 mg hpcddiclofenac respectively and was 3090 and 5617 ngml after the fourth dose indicating no accumulation plasma exposures to 1875 mg 866 nghourml and 375 mg 1843 nghourml iv hpcddiclofenac bracketed that of oral cataflam 50 mg 1473 nghourmlconclusions study 1 bioavailability in terms of auc after iv administration was equivalent for hpcddiclofenac compared with voltarol and after im administration of hpcddiclofenac and voltarol bioavailability in terms of auc after im administration of hpcddiclofenac was equivalent to iv administration of hpcddiclofenac and iv administration of voltarol study 2 hpcddiclofenac showed dose proportionality after single and multipledose administration and no accumulation of hpcddiclofenac hpcddiclofenac was safe and well tolerated following iv and im administration