NCT07584304尚未招募1 期
An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508C and YHR2603 in Healthy Subjects
Yuhan Corporation0 个研究点目标入组 44 人开始时间: 2026年7月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
研究概览
简要总结
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects
详细描述
44 healthy subjects will be randomized to one of 2 groups in the same ratio.
Subjects in group 1 will be administered "YHR2603" and "YHP2508C" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508C" and " YHR2603" by crossover design on periods 1 to 4.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 54 Years（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 investigational products within 6 months prior to the first administration.
- •Those who are judged ineligible to participate in the trial by the principal investigator.
- •Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
研究者
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