A Phase 1, Open Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Following Single And Multiple Intravenous Infusion In Healthy Japanese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Plasma metronidazole pharmacokinetic parameters for single dose:Cmax
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of metronidazole following single and multiple intravenous infusion in healthy Japanese adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and/or female subjects.
排除标准
- •Subject with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Subject with history of regular alcohol consumption exceeding 7 drink/week for females or 14 drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months of screening.
研究组 & 干预措施
1.0
干预措施: metronidazole IV 500 mg (Drug)
结局指标
主要结局
Plasma metronidazole pharmacokinetic parameters for single dose:Cmax
时间窗: Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:AUClast
时间窗: Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:AUC0-6
时间窗: Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for single dose:Tmax
时间窗: Day 1 to Day 3
Plasma metronidazole pharmacokinetic parameters for multiple dose:Ctrough
时间窗: prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8
Plasma metronidazole pharmacokinetic parameters for multiple dose:Cmax
时间窗: Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:AUC0-6
时间窗: Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:Tmax
时间窗: Day 8 to Day 9
Plasma metronidazole pharmacokinetic parameters for multiple dose:CL
时间窗: Day 8 to Day 9
次要结局
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Cmax(Day 1 to Day 3)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUClast(Day 1 to Day 3)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: AUC0-6(Day 1 to Day 3)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for single dose: Tmax(Day 1 to Day 3)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Ctrough(prior to Day 3 and Day 6-8 morning dose and 6 hours post morning dose on Day 8)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Cmax(Day 8 to Day 9)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: AUC0-6(Day 8 to Day 9)
- Plasma 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole pharmacokinetic parameters for multiple dose: Tmax(Day 8 to Day 9)