The purpose of this study is to compare the pharmacokinetic and bioavailability characteristics of two test formulations of ibuprofen for rectal administration with the profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).
Ibuprofen is a widely used analgesic and antipyretic in adults and children. Two ibuprofen suppository formulations have been developed for pediatric use to facilitate dosing in younger age groups. This is a single-dose, balanced, randomised, three-period crossover study in healthy male and female adult volunteers. Each volunteer will receive a single dose of 50 mg ibuprofen as a suppository, a single dose of 200 mg ibuprofen as a suppository and a single oral dose of 200 mg ibuprofen (tablet). There will be 14 blood samples taken over 12 hours in each study period. Concentrations in plasma of ibuprofen and its S and R enantiomers will be measured using a validated chromatographic method. Standard pharmacokinetic parameters will be obtained and bioavailability on the basis of rate and extent of drug absorption will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
Each subject will receive single doses of (i) ibuprofen 50 mg suppository (ii) ibuprofen 200 mg suppository and (iii) ibuprofen 200 mg tablet in 3 separate dosing periods. Doses will be administered after an overnight fast.
Shandon Clinic
Cork, Co. Cork, Ireland
Pharmacokinetic parameters, including AUC0-t and AUC0-∞
Time frame: 14 samples over 12 hours in each period
Pharmacokinetic parameters, including Cmax, tmax, t1/2 and Terminal Elimination Rate Constant
Time frame: 14 samples over 12 hours in each period
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