NCT00875966已完成1 期
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions
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
- Sandoz
- 入组人数
- 42
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant findings on physical exam, medial history or laboratory tests on screening
排除标准
- •Positive test for HIV or hepatitis B and C
- •Treatment for Drug or alcohol abuse
- •Any other important criteria in the protocol
研究组 & 干预措施
1
Experimental
Azithromycin for oral suspension 200mg/5mL
干预措施: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC (Drug)
2
Active Comparator
Zithromax (azithromycin for oral suspension) 200mg/5mL
干预措施: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 37 days
次要结局
未报告次要终点
研究者
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