Bioequivalence evaluation of lomefloxacin 400 mg tablets (Lomax((R)) versus Maxaquin((R))) in healthy human volunteers

This study represents the results of a randomized, single dose, two-treatme nt, two-period crossover study in 18 healthy male volunteers to assess the bioequivalence of two tablets of 400 mg lomefloxacin. The two formulations were: Lomax((R)) (Julphar, United Arab Emirates) as the test formulation an d Maxaquin((R)) (Searle, S.A., UK) as the reference formulation. The study was conducted at the College of Pharmacy, King Saud University, Riyadh, Sau di Arabia, jointly with;King Khalid University Hospital, Riyadh, Saudi Arab ia. After overnight fasting the two products were administered as a single dose on two treatment days separated by a 1 week washout period. Serial blo od samples were collected thereafter, for a period of 48 h. Plasma harveste d from blood was analysed fur lomefloxacin by a sensitive, reproducible and accurate HPLC method. Various pharmacokinetic parameters including AUC(0-t ), AUC(0-proportional to), C-max, T-max, T-1/2, K-elm and C-max/AUC(0-infin ity) were determined from plasma concentrations for both formulations and f ound to be in good agreement with reported values. Statistical modules appl ied to AUC(0-t), AUC(0-infinity) and C-max revealed no significant differen ce in the two tested products. Based on these statistical inferences it was concluded that Lomax((R)) is bioequivalent to Maxaquin((R)). Copyright (C) 1999 John Wiley & Sons, Ltd.