Pharmacokinetics and Bioequivalence of Ioxoprofen Sodium Capsules in Chinese Healthy Volunteers

OBJECTIVE To evaluate the pharmacokinetics and relative bioequivalence of domestic Ioxoprofen Sodium capsules (test) and imported tablets (reference) in Chinese healthy volunteers. METHODS 20 Healthy male volunteers randomly received with a single crossover dose of 500 mg ioxoprofen sodium test or reference prepreation ioxoprofen sodium concentrations in the serum were determined by HPLC-UV. The pharmacokinetic parameters of ioxoprofen sodium were analyzed using 3P97 program. RESULTS Ioxoprofen sodium parameters of the capsules and references preparations tablets were as follows:tmax(1.7±0.3), (1.6±0.2)h;ρmax (4.45±1.25),(4.39±1.12)mg·L-1;AUC0-12:(12.11±2.62),(11.72±2.73)mg·h·L-1;t1/2:(1.89±0.45),(1.82±0.33)h;The result of statistical analysis showed no significant differences between the two formulations (P0.05). The relative bioavailability of the ioxoprofen sodium capsules was (96.9±10.2)%. CONCLUSION The two preparations are bioequivalent.