Estudo de bioequivalência entre duas formulações de ciprofibrato 100 mg comprimidos em voluntários sadios após administração de dose única

Comparison of the bioavailability of two formulations of ciprofibrate 100 mg tablets (ciprofibrate 100 mg - Ache Laboratorios Farmaceuticos S/A, test formulation and Oroxadin® 100 mg - Sanofi-Aventis Farmaceutica Ltda, reference formulation) was performed by means of a bioequivalence study with 52 healthy volunteers. The study was carried out using an open-label, randomized, single-dose, two period crossover design, with a nine weeks washout interval. Plasma samples were obtained over a 72 hours interval. Plasmatic concentrations of ciprofibrate were determined by high performance liquid chromatography coupled to mass spectrometry detection (HPLC-MS/MS) with electrospray ionization in positive mode. The pharmacokinetic parameters area under the curve (AUC0-72), maximum plasmatic concentration (Cmax) and maximum time (Tmax) were obtained from the plasmatic concentration - time curve of ciprofibrate. The geometric mean test/reference ratios with 90% confidence interval after log transformation were 89.43% (85.09% - 93.99%) for Cmax and 97.23% (94.73% - 99.79%) for AUC0-72. The test and reference formulations are considered bioequivalents if the 90% confidence intervals for the geometric mean test/reference ratios were within the range of 80% to 125%. Therefore, the tested ciprofibrate 100 mg tablets (Ache Laboratorios Farmaceuticos S/A) were bioequivalents to the Oroxadin® 100 mg tablets, according to the rate and extent of absorption