NCT04431141已完成1 期
A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUCτ,ss of teneligliptin and empagliflozin
研究概览
简要总结
This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit
- •Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit
- •Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions
排除标准
- •History of type 1 diabetes mellitus and/or diabetic ketoacidosis
- •Severe infection, surgery, or severe trauma within 6 months prior to the screening visit
- •Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit
- •Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study
- •Subject determined by the principal investigator to be ineligible for study conduct for other reasons
研究组 & 干预措施
Teneligliptin
Experimental
干预措施: Teneligliptin (Drug)
Empagliflozin
Experimental
干预措施: Empagliflozin (Drug)
Teneligliptin and Empagliflozin
Experimental
干预措施: Teneligliptin and Empagliflozin (Drug)
结局指标
主要结局
AUCτ,ss of teneligliptin and empagliflozin
时间窗: 72 hours
Area under the plasma concentration versus time curve (AUC) at steady state
Cmax,ss of teneligliptin and empagliflozin
时间窗: 72 hours
Peak Plasma Concentration (Cmax) at steady state
次要结局
- Tmax,ss of teneligliptin and empagliflozin(72 hours)
- t1/2β of teneligliptin and empagliflozin(72 hours)
研究者
研究点 (1)
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