Bioequivalence Between an Oral Nicotine Replacement Product 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
- 76
- 试验地点
- 1
- 主要终点
- Pharmacokinetic measurements
研究概览
简要总结
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
详细描述
The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 body mass index (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
UNG-GC-2
2 mg experimental NRT product
干预措施: Nicotine (Drug)
UNG-GC-4
4 mg experimental NRT product
干预措施: Nicotine (Drug)
Nicorette® Gum-2
2 mg Nicorette® Gum
干预措施: Nicotine Gum (Drug)
Nicorette® Gum-4
4 mg Nicorette® Gum
干预措施: 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 (AUC∞)
次要结局
- tmax(Baseline and during 10 hours after product administration)
- Lamda z(Baseline and during 10 hours after product administration)
- Released amount of nicotine(After 30 minutes of chewing)