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.