Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects

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 breastfeeding
• 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, intrauterine device or surgical sterilization plus condom or diaphragm with spermicidal agent) throughout the study period
• Subject must have given signed informed consent
• Subject was within 20% of the 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 ranges and an electrocardiogram (ECG) with no clinically significant abnormalities
• Subject's pre study clinical laboratory findings were within the normal range or if outside of the normal range were not deemed clinically significant in the opinion of the Investigator
• Subject had bilateral patent nasal airways at screening and Day 1 as assessed by the Investigator
• Subject had a body weight of at least 60 kg

Exclusion criteria

• Subject had had a clinically significant illness in the 4 weeks before screening
• Subject had used 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 h prior to dosing. However, use of multivitamins and oral contraceptives was permitted
• Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening
• Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
• Subject was a current user of tobacco or had a history of smoking in the past 5 years
• Subject was in the opinion of the Investigator not suitable to participate in the study
• Subject had participated in any clinical study with an investigational drug/device within 3 months prior to dosing
• Subject had a positive result of human immunodeficiency virus (HIV) screen, hepatitis B screen or hepatitis C screen
• Subject had had a serious adverse reaction or significant hypersensitivity to any drug
• Subject had donated 500 mL or more of blood within the 3 months prior to screening
• Subject had any history of co-existing nasal polyps, nonsteroidal anti-inflammatory drug (NSAID) sensitivity and asthma
• Subject had had an allergic reaction to aspirin or other NSAIDs
• Subject had a current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs)
• Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
• Subject had used a monoamine oxidase inhibitor in the 14 days prior to study entry
• Subject had active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
• Subject had anemia due to unexplained or known gastrointestinal bleeding
• Subject had a history of asthma or any other chronic pulmonary disorder
• Subject had renal impairment or a risk of renal failure due to volume depletion
• Subject had a previous history of nasal surgery