Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations (V0474) Versus Two Reference Formulations (V0018 B mg and Niquitin® Fresh Mint, 4mg) After Single Oral Administration in Healthy Male Smokers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject aged 18 to 45 years (inclusive)
- •Current smoker of < or = 10 cigarettes/day
- •Fagerström score < or = 5
- •Absence of any clinically significant abnormal finding at physical, ECG, biological examinations in the Investigator's opinion
排除标准
- •Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
- •Current or recurrent buccal lesions
研究组 & 干预措施
V0474 - B mg
干预措施: V0474 - B mg (Drug)
V0474 - A mg
干预措施: V0474 - A mg (Drug)
V0474 - C mg
干预措施: V0474 - C mg (Drug)
Niquitin® Fresh Mint 4 mg
干预措施: Niquitin® Fresh Mint 4 mg (Drug)
V0118 - B mg
干预措施: V0018 - B mg (Drug)
结局指标
主要结局
Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers
时间窗: 12 time points up to 6h after oral administration
Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers by measuring Maximum Plasma Concentration (Cmax), Time of Maximum Concentration (Tmax) , Area under the nicotine plasma concentration curve (AUC0-t), for each test and reference formulations
次要结局
- Clinical safety (reported adverse events)(Screening up to Day 5)
- Acceptability questionnaire(Up to complete lozenge dissolution, about 30 minutes (4 times))