Abstract

CUESTA GONZALEZ, Fanny et al. Bioequivalence of two metformin formulations: 850 mg tablets in healthy colombian volunteers. Iatreia [online]. 2005, vol.18, n.3, pp.289-301. ISSN 0121-0793.

INTRODUCTION: Metformin is an orally active antidiabetic agent used to treat type II diabetes; it is found in the Colombian market in both the innovator brand and the generic formulations. The latter have to prove some biopharmaceutical quality outcomes to guarantee interchangeable proprieties. Objective: To determine whether the drug Dimefor^®/Metformina MK is bioequivalent to the reference product Glucophage^®, when the products are administrated, at the same dose, to a group of healthy volunteers. METHOD: The study was made with 24 healthy volunteers who met the inclusion criteria and spontaneously decided to participate after being thoroughly informed. We used a two-sequence threeperiod randomized, crossed and double-blind study. The volunteers took an 850 mg dose of each medicine; then, blood samples were taken throughout 24 hours and the metformin quantification in plasma was determined by High Performance Liquid Chromatography with UV detection (HPLC/UV). For statistical analysis, Schuirmann's test was used. RESULTS: The study showed that both preparations are bioequivalent; confidence intervals for ln AUC0-∞", ln Cmax, ln AUC0-Tmax and Tmax were [84.6-100.0%], [89.1-109.0%], [83.4-1.4%] and [85.1-109.8% ], respectively.

Keywords : bioavailability; bioequivalency; hplc (high performance liquid chromatography); metformin.

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