NCT01879007已完成1 期
Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Vss
研究概览
简要总结
This study seeks to compare the pharmacokinetic characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) with those of Factive 320mg Tablet Formulation (Gemifloxacin 320mg) and to explore possibility of clinical use of the IV formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 Korean males between 19 and 45 years of age, weighing within 15% deviation of the ideal weight (CRC criteria) and residing in Korea (Appendix 4)
- •Applicants judged eligible as subject based on health exams (interview, blood pressure, 12-lead ECG, physical exam, blood and urine tests, and other screening tests) conducted not more than three weeks prior to administration (those with two or less clinically significant results)
- •Applicants who can take part in the whole process of clinical study
- •Applicants who sufficiently received explanation on the purpose and content of clinical study, characteristics of the investigational products, etc., before participating in the study and gave written consent to participate in the study voluntarily
排除标准
- •Applicants who exhibit symptoms suspected to be those of acute diseases prior to the start of the study
- •Clinically significant kidney disease or liver disease
- •Cardiovascular, respiratory, renal, endocrine system, hematology (hemorrhagic diathresis), digestive system (peptic ulcer), central nerve system, psychiatric disorder, or malignant tumors; chronic diseases that can influence the absorption, distribution, metabolism, or excretion of drugs
- •Applicants who have been on an abnormal diet, which can influence the absorption, distribution, metabolism, or excretion of drugs
- •Medical history of gastrointestinal resection except appendectomy
- •Applicants testing positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody;
- •Clinically significant allergic diseases (excluding mild allergic rhinitis that does not require medication)
- •Known history of hypersensitivity to drugs
- •Known history of developing complications such as epilepsy or other convulsive diseases
- •Excessive consumption of caffeine and alcohol or heavy smoker
- •History of alcohol or drug abuse
- •Applicants who cannot take the standard meals provided by ASAN Medical Center(AMC)
- •Donation of whole or apheresis blood prior to the administration
- •Participation in other clinical study as subjects prior to the administration
- •Applicants who have taken prescription drugs prior to the administration or OTC(over-the-counter) drugs prior to the administration and for which such medications are judged by the principal investigator to have an influence on this study or on the safety of the subject
- •Applicants who are highly likely to take other medication during the study
- •Applicants who took medication that induces or inhibits drug-metabolizing enzymes such as barbiturates or consumed excessive amounts of alcohol less than 1 month prior to the administration
- •Medical history of meningitis, encephalitis, or brain injury
- •Difficulty in cooperating with researchers in proceeding with the study
研究组 & 干预措施
group 1
Experimental
received one intravenous administration and one oral medication with interval of 1 week,
干预措施: Factive® Tab / Factive IV (Drug)
group 2
Experimental
received one oral administration and one intravenous medication with interval of 1 week
干预措施: Factive® Tab / Factive IV (Drug)
结局指标
主要结局
Vss
时间窗: Up to 48 hr
F
时间窗: Up to 48 hr
CL
时间窗: Up to 48 hr
AUC
时间窗: Up to 48 hr
Cmax
时间窗: Up to 48 hr
Tmax
时间窗: Up to 48 hr
MRT
时间窗: Up to 48 hr
次要结局
未报告次要终点
研究者
研究点 (1)
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