Trial reportBMC pharmacology & toxicology2026
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.
Trial report in BMC pharmacology & toxicology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesFood 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.
methodsBased 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.
resultsThe 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) mg/L: p < 0.05. fed: (0.094 ± 0.059) mg/L vs (0.145 ± 0.075) mg/L: p < 0.05). After taking EMPA, the elevated urine glucose and decreased β2-MG level exceeded the normal ranges (urine glucose: ˂ 2.8 mmol/24 h. β2-MG: 0.1 ~ 0.3 mg/L). Fasting administration of EMPA increased PRC (p < 0.05) but had no effect on aldosterone levels. Other parameters before and after EMPA administration in both groups had no significant difference and were all within the normal ranges.
conclusionsThe potential effects of long-term HFD on the PK and pharmacological actions of EMPA should be considered. Exploring the relationship between the elevated urine glucose and decreased β2-MG may have certain clinical value. CLINICAL
trial registrationChiCTR2400089102, retrospectively registered in https://www.chictr.org.cn/ on 2 September 2024.
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