Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers

Pfizer17 个研究点分布在 2 个国家目标入组 73 人开始时间: 2007年5月最近更新: 2008年11月19日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Pfizer
入组人数: 73
试验地点: 17
主要终点: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).

研究概览研究设计入排标准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 investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 12 Years 至 16 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male and female adolescents (12 - 16 years inclusive) with a total body weight greater than 30 kg who currently smoke an average of at least 3 cigarettes per day.

排除标准

•Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.

结局指标

主要结局

Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).

次要结局

Pharmacokinetic parameters: Individual predicted estimates of Cmax, Tmax, and AUCτ on Day 14 (steady-state) using the final PK model and individual post-hoc estimates of the PK parameters.

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (17)

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