Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Three Formulations of Ibuprofen in Healthy, Fasting Male and Female Volunteers|
- Pharmacokinetic parameters, including AUC0-t and AUC0-∞ [ Time Frame: 14 samples over 12 hours in each period ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters, including Cmax, tmax, t1/2 and Terminal Elimination Rate Constant [ Time Frame: 14 samples over 12 hours in each period ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||November 2004|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
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.
Other Name: MOTRIN®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921830
|Cork, Co. Cork, Ireland|
|Study Director:||Jerry Cottrell||McNeil UK|