Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - 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
- 104
- 试验地点
- 2
- 主要终点
- Maximum Plasma Concentration
研究概览
简要总结
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
详细描述
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. 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
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects, 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
F NSL4H
Experimental NRT (H) 4 mg
干预措施: Experimental Nicotine Replacement Therapy (NRT) (Drug)
A NSL2L
Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg
干预措施: Experimental Nicotine Replacement Therapy (NRT) 2 mg (Drug)
B Lozenge
Marketed Nicotine Lozenge 2 mg
干预措施: Marketed Nicotine Lozenge (Drug)
C NSL4M
Experimental NRT (M) 4 mg
干预措施: Experimental Nicotine Replacement Therapy (NRT) (Drug)
D Lozenge
Marketed Nicotine Lozenge 4 mg
干预措施: Marketed Nicotine Lozenge (Drug)
E NSL4L
Experimental NRT (L) 4 mg
干预措施: Experimental Nicotine Replacement Therapy (NRT) (Drug)
结局指标
主要结局
Maximum Plasma Concentration
时间窗: during 12 hours after product administration
The maximum observed nicotine concentration in plasma (Cmax)
Area under the Curve
时间窗: after 12 hours
The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
次要结局
- Time of Maximum Concentration(during 12 hours after start of product administration)
- Terminal Elimination Rate Constant(during 12 hours after start of product administration)
- Oral Dissolution Time(from administration until completely dissolved)