Bioequivalence of Two Formulations of Metformin Hydrochloride 1000 mg XR Tablets, Fasting Condition in Healthy Adults Subjects

Background: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. Methods: This was a randomized, single-dose, open-label, two-period, two-sequence, crossover and single-dose study to compare the bioequivalence (BE) profile of Metformin (metformin hydrochloride) 1000 mg XR tablet of Laboratorios Leti S.A.V., with Glucophage？ (metformin hydrochloride) 1000 mg XR tablet of Merck Serono GmbH in 26 adult healthy subjects. The pharmacokinetic (PK) parameters C_max, ${\text{AUC}}_{0？t}$ and ${\text{AUC}}_{0\to \infty }$ were calculated based on the plasma drug concentration-time profile measured by liquid chromatography-mass spectrometry (LC-MS/MS). The safety was assessed throughout the study. The two formulations test (T) and reference (R) were considered bioequivalent if 90% confidence interval (CI) were within BE acceptance range of 80.00% - 125.00% for C_max, ${\text{AUC}}_{0？t}$ and ${\text{AUC}}_{0\to \infty }$ . Results: A total of 25 subjects completed both study periods 90% confidence intervals (CIs) of the test/reference ratios were C_max: 92.30% (89.08% - 96.97%), ${\text{AUC}}_{0？t}$ : 91.83% (87.11% - 94.11%) and ${\text{AUC}}_{0\to \infty }$ : 91.83% (87.23% - 94.85%) to metformin 1000 mg extended release. PK parameters were within the accepted