Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum Concentration
研究概览
简要总结
This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.
详细描述
This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.
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
- Double (Participant, Investigator)
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
A1 Short, no buffer
Nicotine / not yet marketed
干预措施: Nicotine (Drug)
A2 Short, low buffer
Nicotine / not yet marketed
干预措施: Nicotine (Drug)
A3 Short, high buffer
Nicotine / not yet marketed
干预措施: Nicotine (Drug)
B1 Long, no buffer
Nicotine / not yet marketed
干预措施: Nicotine (Drug)
B2 Long, low buffer
Nicotine / not yet marketed
干预措施: Nicotine (Drug)
B3 Long, high buffer
Nicotine / not yet marketed
干预措施: Nicotine (Drug)
R = Nicotine Gum
Nicorette® Gum
干预措施: Nicotine Gum (Drug)
结局指标
主要结局
Maximum Concentration
时间窗: Baseline to 10 hours post-dose
The maximum observed nicotine concentration in plasma (Cmax)
Area under the Curve
时间窗: 10 hours post-dose
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 to Maximum Concentration(10 hours post-dose)
- Residual Nicotine(30 minutes)
- Dissolution Time(10 hours post-dose)