KCT0001628已完成未知
An Open-label, Randomized, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of Aronamin-gold and VitaB 100 Tablet After Single Dosing in Healthy Male Subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy male Korean subject age 20 to 45 at the screening visit
- •2. Subject who is over 50kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20%
- •3. Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination, subject who is no pathological symptoms or findings.
- •4. After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
排除标准
- •1. A person who has acute symptom at screening phase
- •2. A person who has any disease or symptoms which is clinically significant
- •3. A person who had been determined as 'not suitable for study' during healthy examination(medical history, physical exam, lab test, Etc) in screening period
- •4. A person who had some lab data below.
- •-AST or ALT > 1.5 times than normal
- •-Total bilirubin > 1.5 times than normal
- •5. A person who has a history of clinically significant allergy.
- •6. A person who has a history of anaphylaxis.
- •7. A person who has medical history of drug abuse or misuse.
- •8. A person who had enrolled to other clinical trial within the last 60 days.
- •9. A person who had donated blood within the last 60 days or who donated substance of blood with in last 20 days.
- •10. A person who can't take a meal derived from this trial.
- •11. A person who has taken abnormal meals like which can affect to drug Absorbtion, Distribution, Metabolism, Excretion.
- •12. A person who can't stop taking grapefuit contained foods.
- •13. A person who has taken other prescription medicine or oriental drugs within the last 14 days, Or Over the counter drugs within the last 7 days
- •14. A person who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or who can't stop the caffein since 24hours before hospitalization.
- •15. A person who has taken alcohol more than 30g/day or someone who can't stop drinking from 24hours before enrollment to discharging from hospital.
- •16. A person who smoked more than 10 piece of tobacco/day or can't stop smoking from 24hours before enrollment to discharging from hospital.
- •17. A person who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •18. A person who is determined to be unsuitable about participation in clinical trial
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