A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]
研究概览
简要总结
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
- •Body Mass Index within the range 19-27 kilograms/meters^2
排除标准
- •Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit
研究组 & 干预措施
Test nicotine lozenge (2 mg)
2 mg test nicotine lozenge to be chewed.
干预措施: Nicotine (2 mg) (Drug)
Test nicotine lozenge (4 mg)
4 mg test nicotine lozenge to be chewed.
干预措施: Nicotine (4 mg) (Drug)
Reference nicotine lozenge (2 mg)
2 mg reference nicotine lozenge to be chewed.
干预措施: Nicotine (2 mg) (Drug)
Reference nicotine lozenge (4 mg)
4 mg reference nicotine lozenge to be chewed.
干预措施: Nicotine (4 mg) (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]
时间窗: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
AUC(0-t) was evaluated using the trapezoid rule.
Maximum Observed Plasma Concentration [Cmaximum (Max)]
时间窗: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Cmax was depicted from plasma concentration of nicotine.
次要结局
- AUC [0-infinity (Inf)](Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours)
- Time to Reach Maximum Plasma Nicotine Concentration (Tmax)(Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours)
- Apparent Elimination Half-life of Nicotine T(1/2)(Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours)
- Elimination Rate Constant for Plasma Nicotine: K (el)(Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours)