Phase I Study of Pharmacokinetics and Bacteriocidal Activity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax and AUC
研究概览
简要总结
Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer
详细描述
A Randomized, open label, single dose, crossover phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy adult within the range of 19 to 65 years old at the time of screening
- •Body Mass Index(BMI)=17.5~30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2)
- •Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings
- •Doctor checks conducted hematology, blood chemistry, urinalysis and laboratory tests, including an electrocardiogram(EKG) performed during screening tests such as a suitable test subjects who judged
- •The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the Institutional Review Board(IRB)-approved consent form signed by the parties in writing
排除标准
- •One with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence
- •One with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history
- •Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 times the upper limit of the normal range
- •Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g)
- •Take part in other clinical trials within two months
- •Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg
- •The great history of alcohol or drug abuse within 1 year
- •Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
- •More than 20 cigarettes a day smoker
- •Taking medication of a prescription drug or nonprescription within 10 days,
- •Within two months the whole blood donation have, within one month of the apheresis donation have
- •Participate in clinical trials to test drug administration and may be at increased risk due to interpretation of test results, or may interfere with severe supply / chronic medical or mental condition or abnormal laboratory test values in character
- •Pregnant women and lactating mothers
- •Described lifestyle in this protocol can comply with or can not
- •One with other investigator judge to unsuitable
研究组 & 干预措施
A Group
1st oral administration of Zabofloxacin 183mg, 2nd oral administration of Zabofloxacin 367mg and 3rd oral administration of Levofloxacin 250mg
干预措施: Zabofloxacin 183mg (Drug)
A Group
1st oral administration of Zabofloxacin 183mg, 2nd oral administration of Zabofloxacin 367mg and 3rd oral administration of Levofloxacin 250mg
干预措施: Levofloxacin 250mg (Drug)
A Group
1st oral administration of Zabofloxacin 183mg, 2nd oral administration of Zabofloxacin 367mg and 3rd oral administration of Levofloxacin 250mg
干预措施: Zabofloxacin 367mg (Drug)
B Group
1st oral administration of Zabofloxacin 367mg, 2nd oral administration of Levofloxacin 250mg and 3rd oral administration of Zabofloxacin 367mg
干预措施: Zabofloxacin 183mg (Drug)
B Group
1st oral administration of Zabofloxacin 367mg, 2nd oral administration of Levofloxacin 250mg and 3rd oral administration of Zabofloxacin 367mg
干预措施: Levofloxacin 250mg (Drug)
B Group
1st oral administration of Zabofloxacin 367mg, 2nd oral administration of Levofloxacin 250mg and 3rd oral administration of Zabofloxacin 367mg
干预措施: Zabofloxacin 367mg (Drug)
C Group
1st oral administration of Levofloxacin 250mg, 2nd oral administration of Zabofloxacin 183mg and 3rd oral administration of Zabofloxacin 367mg
干预措施: Zabofloxacin 183mg (Drug)
C Group
1st oral administration of Levofloxacin 250mg, 2nd oral administration of Zabofloxacin 183mg and 3rd oral administration of Zabofloxacin 367mg
干预措施: Levofloxacin 250mg (Drug)
C Group
1st oral administration of Levofloxacin 250mg, 2nd oral administration of Zabofloxacin 183mg and 3rd oral administration of Zabofloxacin 367mg
干预措施: Zabofloxacin 367mg (Drug)
结局指标
主要结局
Cmax and AUC
时间窗: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Maximum of Concentration(Cmax) Area Under Plasma Concentration-Time Curve(AUC)
次要结局
- Pharmacokinetic Profile of Plasma(Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours)
- Pharmacokinetic Profile of Urine(Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours)
- Bactericidal Activity Profile of Urine(Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours)