Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers.

Author(s): Harahap Y, Prasaja B, Indriati E, Lusthom W, Lipin

Affiliation(s): Department of Pharmacy, Faculty of Mathematics and Sciences, University of Indonesia. yahdiana03@yahoo.com

Publication date & source: 2007-06, Int J Clin Pharmacol Ther., 45(6):373-6.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 and24h 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 AUC0-24h, AUC0-infinity and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated non-parametrically. RESULTS: The point estimates and 90% confidence intervals for AUC0-24h, AUC0-infinity and Cmax 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.