NCT00452894已完成1 期
A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.
研究概览
简要总结
This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive.
- •Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.
- •Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year.
排除标准
- •Heart rate>100 bpm, QRS Interval>120 msec, QTc Interval >430 msec, PR Interval>220 msec, or any other abnormalities observed on the Electrocardiogram.
- •Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.
- •Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.
结局指标
主要结局
The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.
次要结局
- To gather safety data from Day 0 to Day 17 of the study.
研究者
研究点 (1)
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