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Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects

Abstract Objective The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet versus a brand-named empagliflozin tablet (Jardiance®) and evaluate the food effects on the pharmacokinetics (PK) of empagliflozin in healthy Chinese subjects. Methods Forty-eight healthy volunteers were included in this randomized, open-label, crossover, two-period study (fasting: n = 24, fed: n = 24). A single dose of 25-mg generic (or test) or brand-named (or reference) empagliflozin was administered to each subject in a randomized sequence. Blood samples were collected at the baseline and during the 72 h post-dose, and plasma empagliflozin concentrations were determined by high performance liquid chromatography–tandem mass spectrometry (HPLC–MS/MS). Pharmacokinetic parameters were analyzed with non-compartmental methods. Safety was monitored. Results The major PK parameters including C max, AUC0– t , and AUC0-∞ were similar between the generic and brand-named tablets under fasting and fed conditions (all p > .05). The 90% confidence intervals of the test/reference ratios of log-transformed C max, AUC0– t , and AUC0-∞ were 94.90–106.70%, 100.62–106.99%, and 100.64–106.85%, respectively, under fasting condition, and 94.21–104.91%, 97.31–101.79%, and 97.32–101.83%, respectively, under fed condition. High-fat food did not affect C max, AUC0– t , AUC0–∞, or T max of empagliflozin (all p > .05). There was no serious adverse event during the study period. Conclusion The generic formulation of empagliflozin tablet is bioequivalent to the brand-named product in healthy Chinese volunteers, and well tolerated. High-fat food had no effects on the PK of empagliflozin in healthy Chinese volunteers.