NCT07102719已完成1 期
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Coadministration of Teneligliptin and Empagliflozin High in Healthy Volunteers
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 HDP023 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 and 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
- AUC∞ of Teneligliptin and Empagliflozin(72 hours)
- AUCt/AUC∞ of Teneligliptin and Empagliflozi(72 hours)
- Tmax of Teneligliptin and Empagliflozin(72 hours)
- VZ/F of Teneligliptin and Empagliflozin(72 hours)
- CL/F of Teneligliptin and Empagliflozin(72 hours)
研究者
研究点 (1)
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