Pharmacokinetic Comparison and Bioequivalence Evaluation of Two Empagliflozin/Metformin Fixed-Dose Combination Tablets in Healthy Subjects under Fed Conditions
Abstract
Background: Empagliflozin, an SGLT2 inhibitor, and Metformin, a biguanide, are commonly prescribed together for the management of type 2 diabetes. This study evaluates the bioequivalence of a fixed-dose combination of Empagliflozin and Metformin (12.5/1000 mg) in healthy subjects under fed conditions. The goal is to ensure that generic versions deliver the same therapeutic effect as the reference product. Materials and Methods: This study was a randomized, open-label, two-period, two-sequence, crossover trial aimed at evaluating the bioequivalence (BE) profiles of two fixed-dose combinations (FDCs) of Empagliflozin and Metformin. The assessment of bioequivalence focused on the maximum plasma concentration (Cmax), area under the concentration-time curve from time zero to time t (AUC0-t), and area under the concentration-time curve from time zero to infinity (AUC0-∞) for both the test and reference formulations. Out of 46 screened participants, 17 were enrolled, of whom 15 completed both treatment periods. In each period, serial blood samples were collected for a duration of up to 72 hours following the oral administration of the study medications. Plasma concentrations of Empagliflozin and Metformin were quantified using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodology. The drug products were deemed bioequivalent if the 90% confidence interval (CI) for the test/reference ratios was within the range of 80.00% to 125.00% for the natural…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 46 participants or records.
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