NCT00865670已完成1 期
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets 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
- 38
- 主要终点
- Bioequivalence according to US FDA guidelines
研究概览
简要总结
To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening
排除标准
- •Positive test results for HIV or hepatitis B or C
- •Treatment for drug or alcohol dependence
- •Female subjects who are pregnant or lactating
研究组 & 干预措施
1
Experimental
Azithromycin Monohydrate 600mg Tablets
干预措施: Azithromycin Monohydrate 600 mg Tablets (Drug)
2
Active Comparator
Zithromax (azithromycin dihydrate)600mg Tablets
干预措施: Zithromax (azithromycin dihydrate) 600 mg Tablets (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines
时间窗: 32 days
次要结局
未报告次要终点
研究者
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