TITLE:
Bioequivalence Assessment of Two Fixed-Dose Formulations of Empagliflozin/Linagliptin (25 mg/5 mg) Coated Tablets in Healthy Subjects under Fasting and Fed Conditions
AUTHORS:
Evelyn Pena, Alfredo Inatti, Anyoli Taly, José Gregorio Chacón, Martin Xenon Serrano
KEYWORDS:
Bioequivalence, Fixed-Dose Combination, Empagliflozin, Linagliptin
JOURNAL NAME:
Journal of Biosciences and Medicines,
Vol.13 No.10,
October
27,
2025
ABSTRACT: Objective: This study compared the pharmacokinetic and safety profiles of two fixed-dose combinations (FDCs) and the mean ratios of the test to reference formulations of empagliflozin/linagliptin (25 mg/5 mg) coated tablets, evaluating the bioequivalence within both formulations under two conditions. Methods: Two open-label, randomized, single-dose, two-period crossover studies were conducted under fasting (n = 32) and fed (n = 32) conditions. Eligible healthy subjects received a single oral dose of empagliflozin/linagliptin of test or reference formulations, followed by a 42-day washout interval between period I and period II. A total of 16 blood samples were collected up to 72 h after administration in each period. The primary pharmacokinetic (PK) parameters were calculated using the non-compartmental method. Bioequivalence (BE) was established for both studies, as the 90% confidence interval of the ratio of adjusted geometric mean (GMR) for Cmax and AUC0-72 was contained within the predefined BE criteria range of 80% - 125%. Results: The 90% confidence intervals (CIs) for the GMR of the test and reference formulations were: Cmax (88.56% - 102.75%), AUC0-72 (88.46% - 97.50%) for empagliflozin, and Cmax (81.88% - 97.23%), AUC0-72 (86.68% - 104.09%) for linagliptin under fasting conditions. The PK parameters of Cmax (87.17% - 100.94%), AUC0-72 (80.78% - 92.02%) were reported for empagliflozin, and Cmax (90.83% - 105.94%), AUC0-72 (86.12% - 109.51%) were reported for linagliptin under fed conditions. Conclusion: The BE of two FDC formulations, empagliflozin/linagliptin, 25 mg/5 mg, coated tablets as the test product and Jardianz® DPP, (empagliflozin/linagliptin) 25 mg/5 mg coated tablets as the reference product, were demonstrated under fasting and fed conditions. No adverse events were reported.