NCT00858195已完成1 期
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting 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
- 36
- 主要终点
- Bioequivalence according to US FDA guidelines.
研究概览
简要总结
The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.
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 abnormal findings 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
- •No allergies to indomethacin or related drugs
研究组 & 干预措施
1
Experimental
Indomethacin 75mg ER Capsules
干预措施: Indomethacin 75mg Extended-Release Capsules, Sandoz (Drug)
2
Active Comparator
Indocin 75mg SR Capsules
干预措施: Indocin 75mg SR Capsules (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines.
时间窗: 8 days
次要结局
未报告次要终点
研究者
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