The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum drug concentration in plasma (Cmax)
研究概览
简要总结
An Open-label, One way, Two period Comparative study To Determine The effect of Morning Versus Evening administration of Empagliflozin 10mg on Its Pharmacokinetics And Pharmacodynamics in Healthy Adults
详细描述
Sixteen(16) healthy subjects will receive a single oral dose of Empagliflozin at the evening(Period I) and after a seven days washout period, the same 16 subjects will receive a single oral dose of Empagliflozin at the morning(Period II).
In both Periods(I and II), blood samples will be collected from each volunteer ethylene diamine tetra-acetic acid(KEDTA) containing tubes prior to drug administration then samples will be obtained at 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours(h) after drug administration.
These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.
Urine samples will be collected over the first 24h after oral administration of the drug with sampling being at the following intervals: 0 to 4h, 4 to 8h, 8-12h, 12 to 24hr.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18-45 years at screening.
- •Subject has a Body Mass Index of 18 to 35 kg/m
- •Subject are non smokers or moderate smokers(not more than 5 cigarettes per day)
- •Subject is willing to participate and give their final written consent prior to the commencement of the study procedures
- •Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.
- •Subject has a normal blood pressure and pulse rate, according to the reference normal ranges
排除标准
- •Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- •Subjects who have taken any medication two weeks preceding of the trial starting date.
- •Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- •Gastrointestinal diseases.
- •Renal diseases.
- •Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .
- •Pancreatic disease including diabetes.
- •Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases
- •Hematological disease or pulmonary disease
- •Abnormal laboratory values.
- •Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.
- •Positive HIV test.
- •History of or current abuse of drugs, alcohol or solvents.
- •Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extra-hepatic tumors
- •Autoimmune disorders as Graves disease
- •(Central nervous system (CNS) disorders
研究组 & 干预措施
Experimental Arm
Subjects will receive a single oral dose of Empagliflozin 10 MG Oral Tablet [Jardiance]
干预措施: Empagliflozin 10 MG Oral Tablet [Jardiance] (Drug)
结局指标
主要结局
Maximum drug concentration in plasma (Cmax)
时间窗: 0 up to 4 hours
Maximum drug concentration in plasma measured in (ng/ml)
Area under the plasma concentration-time curve from time 0 to 48 hours(h) (AUC0→48h)
时间窗: From first sampling interval up to 48 hours
Area under the plasma concentration-time curve from time 0 to time(t) measured in(ng.h/ml)
Time to Maximum drug concentration in plasma (tmax)
时间窗: 0 up to 4 hours
Time corresponding to maximum drug concentration in plasma measured in Hours(h)
次要结局
- Half life( t½) of drug in plasma(Up to 48 hours)
- Cumulative Urinary Glucose Excreted over the first 24 hours (Cumulative UGE)(From 0 up to 24 hours)
研究者
Mohamed Raslan
Principal investigator
Ain Shams University