Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - 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
- 88
- 试验地点
- 1
- 主要终点
- Pharmacokinetic measurements
研究概览
简要总结
Bioequivalence between oral nicotine replacement products and Nicorette® gum.
详细描述
This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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 10 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.
研究组 & 干预措施
NRT-2
2 mg single-dose of a new NRT product
干预措施: Nicotine (Drug)
GUM-2
2 mg single-dose of a marketed nicotine gum
干预措施: Nicorette® (Nicotine Gum) (Drug)
NRT-4
4 mg single-dose of a new NRT product
干预措施: Nicotine (Drug)
GUM-4
4 mg single-dose of marketed nicotine gum
干预措施: Nicorette® (Nicotine Gum) (Drug)
结局指标
主要结局
Pharmacokinetic measurements
时间窗: Baseline and during 10 hours after product administration
Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax) * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) * the area under the plasma concentration-vs.-time curve until infinity (AUCinf)
次要结局
- Dissolution Time(From product administration until completely dissolved)
- λz(during 10 hours after start of product administration)
- Tmax(during 10 hours after start of product administration)
- Residual Nicotine(After 30 minutes of chewing)