A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- AUC(0-t) of Nicotine 4 mg Test and Reference Product
研究概览
简要总结
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI within the range of 19 to 30 kilograms/meters^2
- •Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up
排除标准
- •Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
- •Treatment with known hepatic enzyme altering agents
研究组 & 干预措施
Test nicotine gum (2 mg)
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
干预措施: Nicotine (2 mg) (Drug)
Test nicotine gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
干预措施: Nicotine (4 mg) (Drug)
Reference nicotine gum (2 mg)
A single dose of reference nicotine gum (2 mg) to be chewed.
干预措施: Nicotine (2 mg) (Drug)
Reference nicotine gum (4 mg)
A single dose of reference nicotine gum (4 mg) to be chewed.
干预措施: Nicotine (4 mg) (Drug)
结局指标
主要结局
AUC(0-t) of Nicotine 4 mg Test and Reference Product
时间窗: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Cmax of Nicotine 4 mg Test and Reference Product
时间窗: Blood samples to be collected from baseline to 12 hours post-dose
Cmax for 4 mg test was compared with 4 mg reference gum
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
时间窗: Blood samples to be collected from baseline to 12 hours post dose
Cmax for 2 mg test was compared with 2 mg reference gum
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
时间窗: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
次要结局
- Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products(Blood samples to be collected from baseline to 12 hours post dose)
- Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products(Blood samples to be collected from baseline to 12 hours post dose)
- Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products(Blood samples to be collected from baseline to 12 hours post dose)
- Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products(Blood samples to be collected from baseline to 12 hours post dose)