临床试验/NCT00959439

NCT00959439已完成1 期

A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.

Sandoz0 个研究点目标入组 34 人开始时间: 2002年3月最近更新: 2017年3月28日

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: 34
主要终点: Bioequivalence based on AUC and Cmax

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).

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: 21 Years 至 50 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.

研究组 & 干预措施

1

Experimental

Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)

干预措施: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.) (Drug)

2

Active Comparator

Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

干预措施: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.) (Drug)

结局指标

主要结局

Bioequivalence based on AUC and Cmax

时间窗: 55 days

次要结局

未报告次要终点

研究者

发起方

申办方类型

Industry

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