临床试验/NCT01013454

NCT01013454已完成1 期

A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers

Pfizer1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2009年12月最近更新: 2009年12月21日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Pfizer
入组人数: 12
试验地点: 1
主要终点: Varenicline area under the curve from 0 to infinity (AUCinf) and varenicline area under the curve from 0 to the last quantifiable concentration (AUClast), as data permit

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 will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy, Caucasian, male, adult light to regular smokers

排除标准

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
•Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

研究组 & 干预措施

Varenicline transdermal delivery system

Experimental

干预措施: varenicline free base patch (Drug)

结局指标

主要结局

Varenicline area under the curve from 0 to infinity (AUCinf) and varenicline area under the curve from 0 to the last quantifiable concentration (AUClast), as data permit

时间窗: 8 days

次要结局

Evaluation of adverse events (including skin irritation)(8 days)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (1)

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