Bioquivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers

Aim: Determination of the bioequivalence of two ciprofloxacin tablet formulations (test formulation manufactured by Novell Pharmaceutical Laboratories, Indonesia, reference formulation from Quimica Farmaceutica Bayer, Spain). Subjects and methods: 24 healthy volunteers received each of the two ciprofloxacin formulations at a dose of 500 mg in a 2-way crossover design. Blood samples were obtained prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h after drug administration. Plasma concentrations of ciprofloxacin were monitored using high-performance liquid chromatography over a period of 24 h after administration. The pharmacokinetics parameter AUC_{0- 24h}, AUC_0-∞ and C_{m ax} were tested for bioequivalence after log-transformation of data and ratios of t_max were evaluated non-parametrically. Results: The point estimates and 90% confidence intervals for AUC_{0- 24h}, AUC_0-∞ and C_{m ax} were 97.55% (92.71 - 102.6%), 97.63% (92.90 - 102.59%) and 95.84% (89.95 - 102.10%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. Conclusion: These results indicate that two medications of ciprofloxacin are bioequivalent and, thus, may be prescribed interchangeably.