A Randomized, Open-label, Single-dose, 2-sequence, 2-period, Crossover Clinical Trial to Investigate the Bioequivalence Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 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 YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
详细描述
30 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8.
Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" 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
- •Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
- •Acceptable medical history, physical examination and laboratory tests during screening
- •Subjects who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detailed explanation of the purpose, contents, and characteristic of the drug
排除标准
- •History of clinically significant disease
- •Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
- •Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin > 1.5 times of normal upper limit
- •Volunteers considered not eligible for the clinical trial by the investigator
- •Administration of other investigational products within 6 months prior to the first dosing
研究组 & 干预措施
Group 1
15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
干预措施: YHP1906 (Drug)
Group 1
15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
干预措施: YHR1902 (Drug)
Group 2
15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8
干预措施: YHP1906 (Drug)
Group 2
15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8
干预措施: YHR1902 (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 Apixaban
Maximum plasma concentration [Cmax]
时间窗: 0-36 hours
Maximum plasma concentration \[Cmax\] of Apixaban
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)