Pharmacokinetics and safety of ketorolac following single intranasal and intramuscular administration in healthy volunteers.
Ketorolac was administered to 15 healthy volunteers in a phase 1, single-dose, crossover, randomized study. Subjects received open-label randomized 15- and 30-mg intramuscular (i.m.) ketorolac and blinded randomized 15- and 30-mg intranasal (i.n.) ketorolac. The i.n. ketorolac was well tolerated; the only nasal symptoms were some instances of mild irritation. The i.n. ketorolac was rapidly and well absorbed (median tmax, 0.50-0.75 hours), and the half-life was approximately 5 to 6 hours, values that were similar to those following i.m. administration. Relative bioavailability of i.n. compared to i.m. administration at the same doses was approximately 67% to 75%. Dose proportionality was noted between the 15- and 30-mg i.n. and i.m. dose levels. Thus, i.n. ketorolac offers a therapeutic alternative to i.m. administration and may provide benefits in the clinical setting.
McAleer
Sarah D
SD
Medeval Limited, ICON plc, Manchester M15 6SH, UK.
Majid
Oneeb
O
Venables
Esther
E
Polack
Torsten
T
Sheikh
Muhammed S
MS
D000281:Administration, Intranasal; D000328:Adult; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006207:Half-Life; D006801:Humans; D007273:Injections, Intramuscular; D020910:Ketorolac / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D008297:Male
D000894:Anti-Inflammatory Agents, Non-Steroidal; D020910:Ketorolac