NCT00821535已完成1 期
An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma and urine maraviroc concentrations for pharmacokinetic analysis
研究概览
简要总结
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg.
排除标准
- •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 time of dosing).
- •Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.
- •Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.
研究组 & 干预措施
Active group
Other
maraviroc dosing group
干预措施: maraviroc (Selzentry, Celsentri) (Drug)
结局指标
主要结局
Plasma and urine maraviroc concentrations for pharmacokinetic analysis
时间窗: pre-48 hrs post dose
Adverse event monitoring
时间窗: Day 0 to Day 3
Bood pressure, pulse rate
时间窗: Day 0, Day 1, and Day 3
Blood and urine safety laboratory tests
时间窗: Day 0 and Day 3
ECG
时间窗: Day 0 and Day 3
次要结局
未报告次要终点
研究者
研究点 (1)
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