临床试验/NCT00749359

NCT00749359已完成1 期

An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 166 人开始时间: 2008年7月7日最近更新: 2017年8月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 166
试验地点: 1
主要终点: Paroxetine blood levels

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研究点记录与标识符相似试验

研究概览

简要总结

This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

open label treatment

Experimental

On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.

干预措施: Paxil CR (Drug)

结局指标

主要结局

Paroxetine blood levels

时间窗: measured up to 168 hours after a single dose.

次要结局

Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs(measured up to 168 hours after a single dose and throughout study)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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