Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. 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
- 40
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration
研究概览
简要总结
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
详细描述
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m
- •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 or donation or loss of blood within 3 month preceding the first dose of study medication.
- •Prior regular use of nicotine mouth spray
研究组 & 干预措施
Oral Nicotine 24-SA
2 Self-administrations of Experimental Nicotine once every hour
干预措施: Oral Nicotine (Drug)
Oral Nicotine 24
2 administrations of Experimental Nicotine by study personnel once every hour
干预措施: Oral Nicotine (Drug)
Oral Nicotine 48
2 administrations of Experimental Nicotine by study personnel once every 30 minutes
干预措施: Oral Nicotine (Drug)
NiQuitin™ Lozenge 4 mg
1 NiQuitin™ lozenge, administered by study personnel once every hour
干预措施: Nicotine Lozenge (Drug)
Nicorette® Gum 4 mg
1 piece Nicorette® gum, chewed for 30 minutes once every hour
干预措施: Nicotine gum (Drug)
结局指标
主要结局
Maximum Plasma Concentration
时间窗: During the last dosing interval (hour 11-12 post-dose)
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Average Concentration
时间窗: During the last dosing interval (hour 11-12 post-dose)
Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)
次要结局
- Nicotine Plasma Concentration(One hour after start of treatment)
- Time of Maximum Concentration(During the last dosing interval (hour 11-12 post-dose))
- Minimum Plasma Concentration(During the last dosing interval (hour 11-12 post-dose))
- Peak-Trough Fluctuation(During the last dosing interval (hour 11-12 post-dose))