A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)
研究概览
简要总结
Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
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
- •BMI 19-27 kg/m2
- •smokes >10 cigarettes per day for preceeding 6 months
排除标准
- •inability to stop smoking during study
研究组 & 干预措施
Reference
nicotine transdermal patch with the existing polyisobutylene adhesive
干预措施: nicotine (Drug)
Treatement
nicotine transdermal patch with the alternate polyisobutylene adhesive
干预措施: nicotine (Drug)
结局指标
主要结局
Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)
时间窗: Baseline to 32 hours
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Maximum Measured Plasma Concentration (Cmax)
时间窗: Baseline to 32 hours
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.
次要结局
- Time to Maximum Plasma Concentration (Tmax)(Baseline to 32 hours)
- Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)(Baseline to 32 hours)
- Plasma Half-life (t1/2)(Baseline to 32 hours)
- Rate of Elimination (Kel)(Baseline to 32 hours)