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临床试验/NCT00914160
NCT00914160已完成1 期

A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Sandoz0 个研究点目标入组 18 人开始时间: 1993年8月最近更新:
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

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

发起方
Sandoz
申办方类型
Industry

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