A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)
研究概览
简要总结
This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 female subjects (of childbearing or nonchildbearing potential) and/or male subjects
- •Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg and <100 kg.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).
研究组 & 干预措施
active treatment arm
penicillin G benzathine treatment
干预措施: penicillin G benzathine (Drug)
结局指标
主要结局
Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Maximum observed plasma concentration for penicillin G (Cmax)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent volume of distribution (as data permit) (Vz/F)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Time to Cmax (Tmax)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent clearance (as data permit) (CL/F)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Terminal half life (as data permit) (t1/2)
时间窗: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
次要结局
- Number of Subjects experiencing an Adverse Event(Screening up to 28 days after last dose of study medication)