NCT06339788已完成1 期
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
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
- 40
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are 19 years or older on screening
- •Signed informed consent
- •Healthy Volunteer
- •Other inclusion applies
排除标准
- •Clinically relevant/significant findings as evaluated by the investigator
- •Other exclusion applied
研究组 & 干预措施
HD-P023
Experimental
One tablet of HD-P023 by oral
干预措施: HD-P023 (Drug)
Co-administration of Teneligliptin and Empagliflozin High
Active Comparator
One tablet each of Teneligliptin and Empagliflozin High by oral
干预措施: Teneligliptin (Drug)
Co-administration of Teneligliptin and Empagliflozin High
Active Comparator
One tablet each of Teneligliptin and Empagliflozin High by oral
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
时间窗: 72 hours
Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin
时间窗: 72 hours
次要结局
- Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin(72 hours)
- Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin(72 hours)
- Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin(72 hours)
- Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin(72 hours)
- Clearance (CL/F) of Teneligliptin and Empagliflozin(72 hours)
研究者
研究点 (1)
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