Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers

Inclusion Criteria: * Male or female volunteers, aged 18 to 60 years inclusive * Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding * All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilisation) throughout the study period * Subject had given signed informed consent * Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999) * Subject's medical history was considered normal, with no clinically significant abnormalities * Subject was considered to be in good health in the opinion of the Investigator as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal range and an ECG with no clinically significant abnormalities * Subject's pre-study clinical laboratory findings were within normal range or, if outside of the normal range, not deemed clinically significant in the opinion of the Investigator * Subject had bilateral patent nasal airways at screening as assessed by the Investigator * Body weight was at least 70 kg Exclusion Criteria: * Subject had a clinically significant illness in the 4 weeks before screening * Use of prescribed medications in the 3 weeks prior to dosing or over-the-counter preparations for 7 days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted * Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening * Subject had history of alcohol abuse or drank in excess of 28 units per week (males) or 21 units per week (females) * Current tobacco use or a history of smoking within the past 5 years * Subject was, in the opinion of the Investigator, not suitable to participate in the study * Subjects who had participated in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing * Subjects who had a positive result of HIV screen, Hepatitis B screen or Hepatitis C screen * Subjects with a serious adverse reaction or significant hypersensitivity to any drug * Subjects who has donated 500 mL or more of blood within the 3 months prior to screening * Any history of co-existing nasal polyps, NSAID sensitivity and asthma * Allergic reaction to aspirin or other NSAIDs * Current upper respiratory tract infection or other respiratory tract condition that could have interfered with the absorption of the nasal spray or with the assessment of AEs * Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants) * Use of a monoamine oxidase inhibitor in the 14 days prior to study entry * Active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding * Anemia due to unexplained or known gastrointestinal bleeding * History of asthma or any other chronic pulmonary disorder * Renal impairment or a risk of renal failure due to volume depletion * Known sensitivity to lidocaine hydrochloride