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Protocol, case report(s), ethics approvals, informed consent, inclusion and exclusion criteria underlying: The effect of morning versus evening administration of empagliflozin on its pharmacokinetics and pharmacodynamics characteristics in healthy adults: a two-way crossover, non-randomised trial

Citation

ElDash, Rana; Shaheen, Sara; Sabri, Nagwa (2021), Protocol, case report(s), ethics approvals, informed consent, inclusion and exclusion criteria underlying: The effect of morning versus evening administration of empagliflozin on its pharmacokinetics and pharmacodynamics characteristics in healthy adults: a two-way crossover, non-randomised trial, Dryad, Dataset, https://doi.org/10.5061/dryad.7h44j0zt1

Abstract

Background: Empagliflozin is an SGLT2 inhibitor approved for use in patients with Diabetes Mellitus type 2 (DMT2) with- or without other cardiovascular disease. Empagliflozin is taken once daily without rationale on the optimal timing for administration. This study aimed to determine the chronopharmacological effects of morning vs evening administration of empagliflozin 10 mg in Healthy Egyptian adults, by investigating the pharmacokinetics and pharmacodynamics parameters of empagliflozin depending on the intake time. 

Methods: An open label, sequential, two‐way crossover trial comprised two periods with a washout period of 7 days. Pharmacokinetics parameters (tmax (h), Cmax (ng/ml), AUC 0-t (ng.h/ml)) as primary endpoints, and (AUC 0 to ∞(ng.h/ml)) as secondary endpoint were assessed. Method validation was done prior to injection in LC/MS/MS and samples were processed by Liquid-Liquid extraction. The pharmacodynamic profile (UGE 0-24) was determined after method validation (glucose hexokinase method).

Results: Tmax increased by (35%) in the evening phase compared to the morning phase, while Cmax decreased by (-6.5%)in the evening dose compared to the morning dose. Besides, AUC0 to ∞ increased in the evening phase by (8.25%) compared to the morning phase. The mean cumulative amount of glucose excreted; UGE (0-24) increased by (43%) in the evening dose compared to the morning dose

Conclusion: Despite the difference in pharmacokinetics parameters between evening and morning doses, Cmax, AUC0-t, AUC0-∞, didn’t differ on the bioequivalence level. In addition, as UGE (0-24) didn’t statistically differ, thus, we can conclude that there is no statistical significance between the morning and evening doses.

Methods

Informed consent were signed by all the participants before the begining of the study.

Case reports were collected by the resident physician and the clinical pharmacist including their data, medical hstory, physical examination, any abnormal laboratory values,  eligible for inclusion and exclusion criteria, in addition to any comments from the physcian or the pharmacist.