An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 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 YHP2406 and YHR2501 in healthy volunteers
详细描述
62 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.
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
- •BMI 18-30 kg/m2
- •Those without clinically significant congenital or chronic diseases
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
A(RT)
31 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
干预措施: YHP2406 (Drug)
A(RT)
31 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
干预措施: YHR2501 (Drug)
B(TR)
31 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
干预措施: YHP2406 (Drug)
B(TR)
31 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
干预措施: YHR2501 (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve [AUCt]
时间窗: 0-8 hours
Area under the plasma drug concentration-time curve \[AUCt\] of Amoxicillin \& Clavulanic acid
Maximum plasma concentration [Cmax]
时间窗: 0-8 hours
Maximum plasma concentration \[Cmax\] of Amoxicillin \& Clavulanic acid
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf](0-8 Hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf](0-8 Hours)
- Time of peak concentration [Tmax](0-8 Hours)
- Terminal phase of half-life [t1/2](0-8 Hours)