Nicotine Patch Bioequivalence Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Pharmacokinetic profile
研究概览
简要总结
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.
4 single 24hour applications separated by 48hour intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject aged 18 to 45 years (inclusive)
- •Current Smoker of >or = 5 and < or = 15 cigarettes/day
- •Fagerström score < or =5 at selection
- •Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram 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) 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
- •Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch
研究组 & 干预措施
Sequence 1
After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.
Each patch will be applied for 24h.
干预措施: V0116 transdermal patch (Test treatment ) (Drug)
Sequence 2
After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.
Each patch will be applied for 24h.
干预措施: V0116 transdermal patch (Test treatment ) (Drug)
Sequence 2
After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.
Each patch will be applied for 24h.
干预措施: Nicotine transdermal patch (Reference Treatment ) (Drug)
Sequence 1
After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.
Each patch will be applied for 24h.
干预措施: Nicotine transdermal patch (Reference Treatment ) (Drug)
结局指标
主要结局
Pharmacokinetic profile
时间窗: Blood samples will be collected on Days 1, 3, 5 and 7
Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations
次要结局
- Clinical safety (reported adverse events)(up to day 9)