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

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 ...背景：恩格列净是一种钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，获批用于伴或不伴其他心血管疾病的2型糖尿病（Diabetes Mellitus type 2, DMT2）患者。该药物每日给药一次，但目前尚无关于最佳给药时机的相关依据。本研究旨在通过考察10mg恩格列净分别于晨间与晚间给药后的药代动力学与药效动力学参数，明确其在埃及健康成年人群中的时辰药理学效应。 方法：本研究为开放标签、序贯双交叉试验，包含两个给药周期及7天的洗脱期。研究以药代动力学参数tmax（小时）、Cmax（纳克/毫升）、AUC₀-t（纳克·小时/毫升）作为主要终点，以AUC₀→∞（纳克·小时/毫升）作为次要终点进行评估。在液相色谱-串联质谱（LC/MS/MS）进样检测前，完成了方法学验证，样本采用液液萃取法进行处理。药效动力学指标（UGE₀-24）已于方法学验证完成后测定（葡萄糖……）