NCT00844207已完成1 期
A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine In Healthy Adult Subjects
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
- Pfizer
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUClast and Cmax of azithromycin and chloroquine for each treatment.
研究概览
简要总结
The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
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).
- •History of febrile illness within 5 days prior to first dose.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
研究组 & 干预措施
Treatment A
Experimental
Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.
干预措施: Fixed combination of Azithromycin and Chloroquine (Drug)
Treatment B
Active Comparator
A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.
干预措施: Azithromycin and Chloroquine (Drug)
结局指标
主要结局
AUClast and Cmax of azithromycin and chloroquine for each treatment.
时间窗: up to 96 hours post dose on Day 5
次要结局
- Tmax of azithromycin and chloroquine for each treatment cohort.(up to 96 hours post dose on Day 5)
研究者
研究点 (1)
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