A Randomized, Open-label, Single-dose, 4-way Crossover Phase 1 Study to Evaluate the Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects

Dong-A ST Co., Ltd.1 个研究点分布在 1 个国家目标入组 29 人2021年1月13日

适应症Healthy

干预措施DA-8010 5mg (Fasting)DA-8010 5mg (Fed)DA-8010 2.5mg (Fasting)DA-8010 2.5mg (Fed)

概览

阶段: 1 期
干预措施: DA-8010 5mg (Fasting)
疾病 / 适应症: Healthy
发起方: Dong-A ST Co., Ltd.
入组人数: 29
试验地点: 1
主要终点: Peak Plasma Concentration (Cmax)
状态: 已完成
最后更新: 4年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects

注册库

clinicaltrials.gov

开始日期

2021年1月13日

结束日期

2021年3月11日

最后更新

4年前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Dong-A ST Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•Healthy male and female volunteer 19 years to 50 years
•Body weight in the range of 45.0 to 90.0 kg and body mass index in the range of 18 to 30kg/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
•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 Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
•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 who have blood pressure \< 90 mmHg or \>150 mmHg as systolic or \<60 mmHg or \>100 mmHg as diastolic
•Subject who have history of drug abuse or Positive in Urine drug screen test
•Subject who are Positivie in Alcohol breath test on screening
•Subject who have ETC drug or oriental medicine 2 weeks prior to IP administration or OTC drug or health functional food or vitamins 1 week prior to IP administration
•Subject who have taken a drug that induces or inhibits the drug metabolic enzyme (e.g., barbital) within 30 days prior to IP administration
•Subject who have participated in other clinical trials within 6 months prior to the first administration of the IP
•Subject who have had whole blood transfusion within 2 months or the apheresis within 2 weeks prior to the first administration of the IP