BIOEQUIVALENCE OF TWO METFORMIN FORMULATIONS: 850 MG TABLETS IN HEALTHY COLOMBIAN VOLUNTEERS

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 (R)/Metformina MK is bioequivalent to the reference product Glucophage (R), 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 AUC(0-infinity), ln C-max, ln AUC(0-Tmax) and T-max were [84.6-100.0%], [89.1-109.0%], [83.4-01.4%] and [85.1-109.8%], respectively.