Bioequivalence evaluation of norfloxacin 400 mg tablets (Uroxin (R) and Noroxin (R)) in healthy human volunteers

A bioequivalence study of two oral formulations of 400 mg norfloxacin was c arried out in 18 healthy volunteers according to a single dose, two-sequenc e, cross-over randomized design at College of Pharmacy, King Saud Universit y, Riyadh, Saudi Arabia, jointly with King Khalid University Hospital. The two formulations were: Uroxin(R) (Julphar, United Arab Emirates) as test an d Noroxin(R) (Merck Sharpe & Dohme, BV, Netherlands). Both test and referen ce formulations were administered to each subject after an overnight fastin g on 2 treatment days separated. by 1 week wash-out period. After dosing, s erial blood samples were collected for a period of 24 h. Plasma harvested f rom blood, was analysed for norfloxacin by a sensitive, reproducible and ac curate HPLC method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C-max, T-max, T-1/2, and K-el were determined from plasma concentrations for both the formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-infinity), and C-max were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval for test/reference ratio of these parameters were found within a bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Uroxi n(R) is bioequivalent to Noroxin". Copyright (C) 2000 John Wiley & Sons, Lt d.