Comparative Bioequivalence Evaluation of Two Brands of Ofloxacin 200 Mg Tablets (jedcoflacin vs. Tarivid) in 24 Healthy Volunteers: a Randomized, Single-dose, Two-period, Two-sequence Crossover Study

This study was performed to investigate the bioequivalence of two brands of ofloxacin, namely, Jedcoflacin 200 mg/tablet (from Jedco International Pharmaceuticals CO., Egypt, as a generic test product ‘A’) relative to Tarivid 200 mg/tablet (from Aventis Pharma Deutschland GmbH, Germany, as a reference product ‘B’) after a single dose oral administration of 400 mg (2200 mg) to 24 healthy adult volunteers under fasting conditions, for the purpose of registration, approval, and marketing stage. The bio-analysis of clinical plasma samples was accomplished by a HPLC method for the determination of plasma ofloxacin concentrations. Pharmacokinetic parameters, determined by standard non-compartmental methods, and analysis of variance (ANOVA) statistics were calculated using statistical analysis system (SAS) software. The parametric 90% Confidence intervals (CIs) of the least squares mean test/reference ratios were found to be within the confidence limits of 80.00-125.00% for AUC030, AUC0 and Cmax, i.e. 87.10% to 101.95%, 87.49% to 102.19%, and 91.71% to 105.30%, respectively. This single-dose study demonstrated that the test product (A) was found bioequivalent to the reference product (B) following an oral dose of 2x200 mg/ tablet, as per predetermined regulatory criteria for bioequivalence, in the 24 fasting healthy volunteers. Therefore, the two formulations were considered to be bioequivalent.