NCT00859807已完成4 期
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cmax, AUCtlast and AUCinf for amodiaquine.
研究概览
简要总结
The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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.
- •Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
- •An informed consent document signed and dated by the subject or a legally acceptable representative.
排除标准
- •A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
研究组 & 干预措施
Sequence 1 (19 subjects)
Experimental
Period 1: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment.
Period 2: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis); reference treatment).
干预措施: Flavoquine®, Camoquin® Suspension (Drug)
Sequence 2 (19 subjects)
Experimental
Period 1: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis Period 2: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment
干预措施: Flavoquine®, Camoquin® Suspension (Drug)
结局指标
主要结局
Cmax, AUCtlast and AUCinf for amodiaquine.
时间窗: end of study
次要结局
- Cmax and AUC72 for DesethylAQ(end of study)
研究者
研究点 (1)
Loading locations...
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