NCT00914160已完成1 期
A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-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
- 18
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting 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
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 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.
研究组 & 干预措施
1
Experimental
Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)
干预措施: Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc) (Drug)
2
Experimental
Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)
干预措施: Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc) (Drug)
3
Active Comparator
Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
干预措施: Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 31 days
次要结局
未报告次要终点
研究者
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