An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of YHP2511 With YHP2511A in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 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 YHP2511 and YHP2511A 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 "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 19 to 55 years at the time of screening visit.
- •Those whose weight is ≥ 50 kg (≥ 45 kg for females) 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
A (RT)
30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2
干预措施: YHP2511 (Drug)
A (RT)
30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2
干预措施: YHP2511A (Drug)
B (TR)
30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2
干预措施: YHP2511 (Drug)
B (TR)
30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2
干预措施: YHP2511A (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve [AUCt]
时间窗: Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours
Area under the plasma drug concentration-time curve \[AUCt\] of Pitavastatin \& Total Ezetimibe
Maximum plasma concentration [Cmax]
时间窗: Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours
Maximum plasma concentration \[Cmax\] of - Pitavastatin \& Total Ezetimibe
次要结局
未报告次要终点