NCT00731562已完成1 期
Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers
适应症
干预措施
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
- 24
- 试验地点
- 1
- 主要终点
- Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
研究概览
简要总结
- To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
- To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adult smokers
- •18 to 55 years of age
排除标准
- •Sensitivity to varenicline
- •Illegal drug use
- •Pregnant or nursing females
研究组 & 干预措施
Varenicline Controlled Release, Fasted
Experimental
干预措施: Varenicline Tartrate Controlled Release (Drug)
Varenicline Controlled Release, Fed
Experimental
干预措施: Varenicline Tartrate Controlled Release (Drug)
结局指标
主要结局
Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
时间窗: 5 days
Maximum plasma concentration of varenicline
时间窗: 1 day
次要结局
- Safety measures including adverse events(5 days)
研究者
研究点 (1)
Loading locations...
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