NCT00875030已完成4 期
A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) 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
- 40
- 试验地点
- 1
- 主要终点
- Cmax, AUCinf and AUClast, for DHA
研究概览
简要总结
The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Any condition possibly affecting drug absorption.
- •A positive urine drug screen.
- •Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.
研究组 & 干预措施
1.0
Experimental
干预措施: artesunate sachets (Drug)
2.0
Active Comparator
干预措施: Arsuamoon (Drug)
结局指标
主要结局
Cmax, AUCinf and AUClast, for DHA
时间窗: 1 year
次要结局
- Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.(1 year)
- Safety laboratory tests, vital signs, and adverse events.(1 year)
研究者
研究点 (1)
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