NCT05991401已完成1 期
An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
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
- 18
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration of DA-8010 (Cmax)
研究概览
简要总结
This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteer 19 years to 50 years
- •Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
- •In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
- •The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
- •The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire
排除标准
- •Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease, sexual disorder, ophthalmologic or history of such disease
- •Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery)
- •Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
- •Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
- •Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
- •Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items
研究组 & 干预措施
Period 1 or 2 or 3
Experimental
[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
干预措施: DA-8010 5mg (Drug)
Period 1 or 2 or 3
Experimental
[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
干预措施: Clarithromycin 500mg (Drug)
Period 1 or 2 or 3
Experimental
[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
干预措施: Rifampicin 600mg (Drug)
结局指标
主要结局
Peak Plasma Concentration of DA-8010 (Cmax)
时间窗: 0~48hours
Area under the plasma concentration versus time curve of DA-8010 (AUClast)
时间窗: 0~48hours
次要结局
未报告次要终点
研究者
研究点 (1)
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