Bioequivalence of Two Oral Ciprofloxacin Extended-Release Formulations in Healthy Mexican Volunteers

Abstract

Introduction. Oral ciprofloxacin extended-release formulation decreases the risk of treatment failure and prevents the development of antimicrobial resistance. However, non-equivalent formulations lead to subtherapeutic plasma drug concentrations, increasing the risk of such problems. Objective. To determine the bioequivalence of two oral ciprofloxacin extended-release tablet formulations (1,000 mg) in healthy Mexican volunteers. Material and Methods. In this open-label 2 × 2 crossover design study, 26 healthy volunteers were randomly allocated to receive a single dose of the reference drug Cipro XR® (Bayer, Mexico) and the test formulation Ciproflox DM® (Senosiain Laboratories, Mexico). Blood samples were obtained for 24 hours. Ciprofloxacin plasma levels were quantified using a validated liquid chromatography method. Pharmacokinetic parameters were obtained by standard non-compartmental analysis. In order to determine bioequivalence, log-transformed test/reference ratios of Cmax, AUC0-t, and AUC0-inf were compared by an analysis of variance, followed by the 90 % confidence intervals and the Schuirmann bilateral test. Results. The 90 % confidence intervals ranged from 85.69 to 114.31 % for Cmax, 85.16-115.84 % in AUC0-t, and 85.39-114.61 % for AUC0-inf, all cases were within bioequivalence acceptance criteria (80-125 %). Schuirmann test verified the probability that the values were within these criteria (p < 0.05). No side-effects were observed with any treatment. Conclusions. The results obtained demonstrate bioequivalence between the analyzed formulations.