An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration-time curve [AUCt]
研究概览
简要总结
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
详细描述
60 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8
Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.
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
- •Those who are 19 years old or older at the screening visit
- •Those whose weight is > 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
- •Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
- •Those who express their voluntary consent to participate in the trial by signing a written consent
排除标准
- •Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
- •Others who are judged ineligible to participate in the trial by the principal investigator.
- •Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
研究组 & 干预措施
Sequence Group B
30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8
干预措施: YHP2205 (Drug)
Sequence Group A
30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
干预措施: YHP2205 (Drug)
Sequence Group A
30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
干预措施: YHR2401 (Drug)
Sequence Group B
30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8
干预措施: YHR2401 (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve [AUCt]
时间窗: 0-36 hours
Area under the plasma drug concentration-time curve \[AUCt\] of Edoxaban
Maximum plasma concentration [Cmax]
时间窗: 0-36 hours
Maximum plasma concentration \[Cmax\] of Edoxaban
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf](0-36 hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf](0-36 hours)
- Time of peak concentration [Tmax](0-36 hours)
- Terminal phase of half-life [t1/2](0-36 hours)