Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Healthy males or non-pregnant, non-lactating, surgically sterile or post-menopausal females (post-menopausal was defined as > 2 years post-last period and more than 50 years of age), or using an acceptable form of contraception as defined in section 9.3.2 (g)
Aged 18-65 years
Body Mass Index of between 18 and 30 kg/m2

Exclusion Criteria:

Participation in a clinical research study involving investigational drugs or dosage forms within the previous 4 months
Subjects who had sought advice from their GP or consulted a counsellor for abuse or misuse of alcohol, non-medical, medicinal drugs, or other substance-abuse such as solvents. Any current or past use of Class A drugs such as opiates, ecstasy, LSD, and amphetamines (Class B). Volunteers that admitted to past use of cannabis were not excluded as long as they had a negative drugs of abuse test and had been abstinent for at least 12 months
Positive drugs of abuse test result
Regular alcohol consumption in males >21 units per week and females >14 units per week. (one unit of alcohol was defined as 0.5 pint (280 ml) of beer or cider, 1 glass (125 ml) wine, 1 glass (70 ml) of sherry or port, 1 measure (25 ml) of whisky, brandy or rum. For low alcohol drinks, one unit of alcohol was defined as 2 glasses (250 ml) of low alcohol wine and 5 half pints (840 ml) of low alcohol beer)
Current smokers, i.e. those who had smoked within the last 12 months
A breath carbon monoxide reading of greater than 10 ppm either at the pre-study medical examination or on a study day prior to dosing
Females of child bearing potential who were sexually active and either not surgically sterile, post-menopausal or not using a form of acceptable contraceptive (contraceptive pills/injection, condoms with spermicide, IUCDs (coils) and diaphragms with spermicide (only if the woman was 35 or more) or abstinence
Radiation exposure from clinical trials, including that from the present study and from diagnostic X-rays but excluding background radiation, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No subject whose occupational exposure is monitored will participate in the study
Clinically significant abnormal biochemistry, haematology or urinalysis
Screening FEV1 < 80% of the predicted value for their age, sex, height and race
History of chronic respiratory disorders or bronchospasm
History of adverse reaction or allergy to ketorolac or di-sodium EDTA
History of severe or multiple allergies, including hayfever and perennial rhinitis
History of adverse reaction or allergy to aspirin or any other non-steroidal anti inflammatory drug (e.g., ibuprofen, flurbiprofen, ketoprofen or diclofenac)
History of infantile bronchiolitis, or a history or the presence of asthma, or wheezy respiration, hayfever and perennial rhinitis
History of nasal fracture, nasal deformity or nasal polyps
History of disease, surgery, or abnormality of the upper respiratory tract, especially the nasal cavity
History of significant nose bleeds
Sinusitis within four weeks of the first study period
Nasal jewelry or nasal piercings
Subjects using topical nasal medication e.g. decongestants, within 14 days prior to the first dosing day
Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the previous 3 months
Subjects taking any medication that might affect the respiratory tract within 14 days of the first study day
Non-prescription and prescription medication (including vitamins and natural or herbal remedies eg. St Johns Wort) within 14 days of the first study day (oral contraceptives, contraceptive implants or depot injections, intra-uterine devices with hormonal implants, Hormone Replacement Therapy (HRT) and occasional paracetamol (up to 4 g daily) were permitted)
History of peptic ulceration or gastrointestinal bleeding
History of kidney disease
History of clotting disorders
Failure to satisfy the Principal Medical Investigator of fitness to participate for any other reason