Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method.
研究概览
简要总结
Background: The current study is a randomized, open-label, two-period, two-sequence, two-way crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the pharmacokinetics and bioequivalence profile of two formulations of empagliflozin 10-mg under fasting and fed conditions administered orally.; (2) Methods: The plasma concentrations of empagliflozin were determined using High-performance liquid chromatography- Mass Spectrometry/ Mass Spectrometry (HPLC-MS/MS) method. This study included 26 subjects, 26 in each fasting and fed group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Jordanian volunteers
- •some private hospitals (Amman, Jordan) Phase I Clinical Unit
排除标准
- •heavy drinkers
- •those who used CYP enzyme inhibitors within the previous 60 days
- •those who had taken any medicine within the previous four weeks
- •those who had a history of medication allergies
- •those who had participated in previous clinical studies within the previous six months
- •those with any significant clinical abnormality
研究组 & 干预措施
Fasting state
干预措施: Empagliflozin 10 mg Tab (Drug)
Fed state
干预措施: Empagliflozin 10 mg Tab (Drug)
结局指标
主要结局
The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method.
时间窗: 5 months
The plasma concentration of empagliflozin under fasting and fed conditions states were measured using HPLC-MS/MS method and recorded in nmol\\L.
次要结局
未报告次要终点