Nicotine Patch - Bioequivalence Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
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
- 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 = 5 and < or = to 15 cigarettes/day
- •Fagerström score < or =5 at selection
- •Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.
排除标准
- •Presence of any significant medical findings 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 safety assessment of a transdermal patch
研究组 & 干预措施
Treatment-Sequence 1
Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.
干预措施: Reference treatment : Nicotine transdermal patch (Drug)
Treatment-Sequence 1
Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.
干预措施: Test treatment : V0116 transdermal patch (Drug)
Treatment-Sequence 2
Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.
干预措施: Test treatment : V0116 transdermal patch (Drug)
Treatment-Sequence 2
Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.
干预措施: Reference treatment : Nicotine transdermal patch (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: During the third application of each period,12 time points up to 24h after the application
Time to Maximum Concentration (Tmax)
时间窗: During the third application of each period,12 time points up to 24h after the application
Area under the plasma concentration-time curve (AUC)
时间窗: During the third application of each period, 12 time points up to 24h after the application
次要结局
未报告次要终点