Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 346
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC): Urges to Smoke-vs-Time
研究概览
简要总结
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
详细描述
This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.
The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.
Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
- •Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
- •Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- •A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
排除标准
- •Pregnancy, lactation or intended pregnancy.
- •Treatment with an investigational product within one month preceding the first dose of study medication.
研究组 & 干预措施
Experimental NRT
A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.
干预措施: Nicotine (Drug)
Nicotine GUM
A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.
干预措施: Nicotine (Drug)
结局指标
主要结局
Area Under the Curve (AUC): Urges to Smoke-vs-Time
时间窗: During 5 hours post-dose
Area under urges to smoke-vs.-time curve
次要结局
- Amount of Nicotine Released(30 minutes)