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Pharmacokinetics and Safety of Ketorolac Following Single Intranasal and Intramuscular Administration in Healthy Volunteers

From Medeval Limited, a Division of ICON plc, Skelton House, Manchester Science Park, Lloyd Street North, Manchester, United Kingdom.

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 (IM) ketorolac and blinded randomized 15- and 30- mg intranasal (IN) ketorolac. The IN ketorolac was well tolerated; the only nasal symptoms were some instances of mild irritation. The IN ketorolac was rapidly and well absorbed (median t_max, 0.50-0.75 hours), and the half-life was approximately 5 to 6 hours, values that were similar to those following IM administration. Relative bioavailability of IN compared to IM administration at the same doses was approximately 67% to 75%. Dose proportionality was noted between the 15- and 30-mg IN and IM dose levels. Thus, IN ketorolac offers a therapeutic alternative to IM administration and may provide benefits in the clinical setting.

Key Words: Ketorolac • intranasal • intramuscular • pharmacokinetics • volunteers

Address for reprints: Oneeb Majid, ICON Development Solutions, Medeval Limited, Skelton House, Lloyd Street North, Manchester M15 6SH, UK.

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