临床试验/NCT00800475

NCT00800475已完成1 期

A Relative Bioequivalence Study of 600 mg Gemfibrozil Tablets Under Fasting Conditions

Blu Caribe0 个研究点目标入组 40 人开始时间: 2005年7月最近更新: 2013年8月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 40
主要终点: Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

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 determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.

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

•healthy men or women 18 years of age or older
•weight within +/- 20% for height and body frame
•willing to participate and sign a copy of the informed consent form

排除标准

•recent history of drug or alcohol addiction or abuse
•pregnant or lactating women
•history of allergic response to gemfibrozil
•use of tobacco products
•evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
•receipt of any drugs as part of a research study within 28 days prior to study dosing

研究组 & 干预措施

Test Drug

Active Comparator

干预措施: Gemfibrozil Tablets (Drug)

Reference Drug

Active Comparator

干预措施: Gemfibrozil Tablets (Drug)

结局指标

主要结局

Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

次要结局

未报告次要终点

研究者

发起方

Blu Caribe

申办方类型

Industry

责任方

Sponsor

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