NCT05992428已完成1 期
An Open-label, 2-Part, Phase 1 Clinical Trial to Evaluate Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron 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
- 37
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
This is an open-label, 2-Part, phase 1 study to evaluate drug interactions when DA-8010 is co-administered with Paroxetine or Mirabegron in healthy adult subjects
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
- •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
- •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 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 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 appendic 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
Part 1 or 2
Experimental
[Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg
干预措施: DA-8010 5mg (Drug)
Part 1 or 2
Experimental
[Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg
干预措施: Paroxetine 20mg (Drug)
Part 1 or 2
Experimental
[Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg
干预措施: Mirabegron 50mg (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 0~48hours
PK Parameter
Area under the plasma concentration versus time curve of DA-8010 (AUClast)
时间窗: 0~48hours
PK Parameter
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy VolunteersHealthy VolunteerNCT01814709Genentech, Inc.32
已完成
1 期
To Evaluate the Effect of Clarithromycin on the Systemic Exposure of Pacritinib in Healthy SubjectsDrug Interaction StudyNCT02807051CTI BioPharma20
已完成
1 期
A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy ParticipantsHealthy ParticipantsNCT01929876Genentech, Inc.16
已完成
1 期
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.HIVAIDSOral ContraceptiveNCT00739622Tibotec Pharmaceuticals, Ireland18
已完成
1 期
A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy SubjectsCystic FibrosisNCT03516331Flatley Discovery Lab LLC16