NCT02097043已完成1 期
A Block-randomized, Double-blind, Placebo-controlled, Single-dose, Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Korean 19-45 years
- •Body weight:55-90kg, BMI:18.0-27.0
排除标准
- •Present condition or history of any clinically significant disease
- •Clinical evidence or history of GI disease or history of GI surgery
- •History of hypersensitivities, including drug allergies
- •AST (SGOT) or ALT (SGPT) > 1.5 times the upper normal limit
- •Systolic blood pressure : <100 mmHg or >160 mmHg
- •Diastolic blood pressure : <60 mmHg or >100 mmHg
- •Drug abuse within 2 months, or a positive reaction to an abusive drug or cotinine
- •Taken any ETC or herbal supplement within 2 weeks or any OTC or vitamin supplement within 1 week
- •Participation in and administration of IP of another clinical trial within 2 months
- •Donation of whole blood within 2 months, or blood components within 1 month, or receipt of blood transfusion within 1 month
- •Consumption of more than 21 units of alcohol/week or inability to abstain from drinking during the study period
- •Smoking within 3 months
- •Taking caffeine- or grapefruit-containing products within 3 days
- •Plan to be pregnant, or not to use an appropriate method of contraception
研究组 & 干预措施
[Group 1] DA-7218
Experimental
200mg, By mouth or orally (PO) & intravenous(IV) administration
干预措施: DA-7218 (Drug)
[Group 1] Placebo
Placebo Comparator
Placebo, By mouth or orally (PO) & intravenous(IV) administration
干预措施: Placebo (Drug)
[Group 2] DA-7218
Experimental
400mg, By mouth or orally (PO) administration
干预措施: DA-7218 (Drug)
[Group 2] Placebo
Placebo Comparator
Placebo, By mouth or orally (PO) administration
干预措施: Placebo (Drug)
[Group 3] DA-7218
Experimental
600mg, By mouth or orally (PO) administration
干预措施: DA-7218 (Drug)
[Group 3] Placebo
Placebo Comparator
Placebo, By mouth or orally (PO) administration
干预措施: Placebo (Drug)
结局指标
主要结局
AUClast
时间窗: 72 hours
Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method
Cmax
时间窗: 72 hours
次要结局
- tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1)(72 hours)
研究者
研究点 (1)
Loading locations...
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