Pharmacokinetic and Bioequivalence Studies of Ibuprofen Suspension after a Single-dose Administration in Healthy Chinese Volunteers

摘要

Objective: The aim of this study was to assessed the pharmacokinetic and bioequivalence of 2 formulations of ibuprofen suspension. Method: 20 healthy volunteers were enrolled into this random, single-dose, 2-way crossover, open-label, single-centre, pharmacokinetic study. After overnight fasting, 2 formulations (test and reference) of ibuprofen (400 mg ibupro-fen/20mL suspension) were administered as a single dose on 2 treatment days separated by a 7-day washout period. After dosing, blood samples were drawn for a period of 12 h. The plasma samples were analyzed for the presence of ibuprofen by HPLC with ultraviolet detection. Pharmacokinetic parameters were determined from plasma concentrations for both formulations.