A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- YHR1705, YHR1706 AUCtau
研究概览
简要总结
This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
详细描述
This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- •Administration of other investigational products within 3 months prior to the first dosing
- •Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
研究组 & 干预措施
1
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
干预措施: YHR1705 (Drug)
1
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
干预措施: YHR1706 (Drug)
1
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
干预措施: YHR1705+YHR1706 (Drug)
2
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1705 (Drug)
2
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1706 (Drug)
2
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1705+YHR1706 (Drug)
3
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1705 (Drug)
3
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1706 (Drug)
3
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1705+YHR1706 (Drug)
4
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
干预措施: YHR1705 (Drug)
4
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
干预措施: YHR1706 (Drug)
4
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
干预措施: YHR1705+YHR1706 (Drug)
5
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
干预措施: YHR1705 (Drug)
5
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
干预措施: YHR1706 (Drug)
5
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
干预措施: YHR1705+YHR1706 (Drug)
6
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1705 (Drug)
6
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1706 (Drug)
6
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
干预措施: YHR1705+YHR1706 (Drug)
结局指标
主要结局
YHR1705, YHR1706 AUCtau
时间窗: 0 - 24hours
AUCtau
YHR1705, YHR1706 Css, max
时间窗: 0 - 24hours
Css,max
次要结局
未报告次要终点