A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers
详细描述
32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.
Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- •Acceptable medical history, physical examination, laboratory tests and EKG, 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 detail explanation of the purpose, contents, and characteristic of the drug
排除标准
- •History of clinically significant disease
- •Sitting blood pressure meeting the following criteria at screening:
- •140 ≤ systolic blood pressure ≤90 (mmHg)
- •90 ≤ diastolic blood pressure ≤ 60 (mmHg)
- •Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit or Total bilirubin > 2.0 mg/dl at the time of screening
- •Volunteers considered not eligible for the clinical trial by the investigator
- •Administration of other investigational products within 6 month prior to the first dosing.
研究组 & 干预措施
Group1
16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8
干预措施: YHP1903 (Drug)
Group1
16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8
干预措施: Champix (Drug)
Group2
16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8
干预措施: YHP1903 (Drug)
Group2
16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8
干预措施: Champix (Drug)
结局指标
主要结局
AUCt
时间窗: 0-96 hours
AUCt of Varenicline
Cmax
时间窗: 0-96 hours
Cmax of Varenicline
次要结局
- AUCinf(0-96 hours)
- Tmax(0-96 hours)
- t1/2(0-96 hours)