NCT00894660已完成1 期
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy 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
- 38
- 试验地点
- 1
- 主要终点
- AUC and Cmax of amodiaquine
研究概览
简要总结
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 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 21 and 55 years, inclusive.
- •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
- •Evidence or history of clinically significant abnormalities.
- •A positive urine drug screen, history of regular alcohol consumption.
研究组 & 干预措施
Amodiaquine (Pfizer)
Experimental
干预措施: Amodiaquine (Test) (Drug)
Amodiaquine tablets (Arsuamoon-Guilin China)
Active Comparator
干预措施: Amodiaquine (Comparator) (Drug)
结局指标
主要结局
AUC and Cmax of amodiaquine
时间窗: 1 month
次要结局
- Tolerability(1 month)
研究者
研究点 (1)
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