To investigate the effect of a high-fat diet on pharmacokinetics/renal function/RAAS-related parameters after a single dose of empagliflozin in healthy Chinese adults
Abstract
OBJECTIVES: Food intake affects pharmacokinetic (PK) parameters of empagliflozin (EMPA). In the treatment of chronic kidney disease, EMPA in combination with renin-angiotensin-aldosterone system (RAAS) inhibitors is widely used. This study aims to investigate how a high-fat diet (HFD) affects the PK parameters, pharmacodynamic (PD) parameters related to renal function, and PD parameters related to RAAS of EMPA. METHODS: Based on a bioequivalence study of healthy Chinese adults, twenty blood sampling points were set up for each participant before EMPA and within 48 hours after 10 mg EMPA administration to measure their plasma concentrations, and then calculate their maximum plasma concentration (Cmax) and area under the time-concentration curve (AUC0~t). Urine and blood glucose, uric acid, blood urea nitrogen, serum creatinine, insulin, urine β2-microglobulin (β2-MG) and α1-MG, plasma renin concentration (PRC), angiotensin II, and aldosterone levels were tested. RESULTS: The 90% confidence intervals of the geometric mean ratios of the fasting Cmax and AUC0~t for the fed group were (152.29~178.77)% and (127.21~147.29)%, not within the bioequivalence range (80.00%~125.00%). When after taking EMPA compared to before taking EMPA, urine glucoses elevated significantly (fasting: (70.9 ± 29.9) mmol/L vs (0.3 ± 0.2) mmol/L: p < 0.001. fed: (89.6 ± 35.4) mmol/L vs (0.3 ± 0.3) mmol/L: p < 0.001), but β2-MG levels decreased significantly (fasting: (0.080 ± 0.065) mg/L vs (0.148 ± 0.054)…
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