Pharmacokinetics and Bioequivalence of two Empagliflozin Tablet Formulations: Results From a Randomized, Open-Label, Crossover Study in Fasting Healthy Volunteers
Abstract
This study aimed to assess the bioequivalence of a newly developed generic formulation of empagliflozin in comparison with the reference product. A total of 32 healthy adult volunteers participated in an open-label, randomized, balanced, two-treatment, two-sequence, two-period crossover study. Following an overnight fast, each participant received a 25 mg single oral dose of either the test or the reference empagliflozin with a 1-week washout period between treatments. Safety was monitored throughout the study, and 21 blood samples were collected at pre-dose and at multiple time points from 0.5 to 48 h post-dose. Plasma concentrations of empagliflozin were quantified using a validated LCMS/MS method following liquid-liquid extraction. Pharmacokinetic parameters were calculated using non-compartmental analysis and statistically compared between formulations using multivariate analysis of variance. The test formulation was well tolerated under fasting conditions, with no serious adverse events reported. The pharmacokinetic parameters, including Cmax and AUC0- t, were not significantly different between the test and reference products. The 90% confidence intervals of the Ln-transformed pharmacokinetic parameters fell within the bioequivalence acceptance range of 80.00% to 125.00%. In conclusion, the test and reference formulations of empagliflozin 25 mg are bioequivalent under fasting conditions in healthy individuals.
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: 32 participants or records.
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