EUCTR2010-024445-78-SE进行中（未招募）不适用
icotine plasma concentrations and subjective effects of a single dose of Nicachet 4 mg nicotine oromucosal powder in pouch compared with 4mg Nicorette chewing gum and 1mg Nicorette nasal spray. - Nicotine oromucosal powder in pouch
Magle AB0 个研究点目标入组 20 人开始时间: 2011年1月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Consent to participate voluntarily and sign Informed Consent prior to any study procedure.
- •2. Healthy male and female, age 18 through 50 years.
- •3. Willing and able to take oral medication.
- •4. Willing and able to comply with the study specific procedures.
- •5. Smoker of >7 cigarettes/day.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of snuff.
- •2. Second or third degree AV block or sick sinus syndrome; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of > 450 msec for male and females or > 470 msec for female and females); other clinically significant heart conditions which would negatively impact on the patient completing the study.
- •3. Subjects with clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in total bilirubin, alkaline phosphatase, LDH, ASAT, or ALAT of > 3 times the upper limit of the laboratory reference interval.
- •4. Subjects with clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine of > 1.5 times the laboratory reference.
- •5. Surgery within 6 months of the Baseline visit that, in the opinion of the investigator, could negatively impact on the patient’s participation in the clinical study.
- •6. Subjects who are participating in other drug studies or who have received other investigational drugs within 30 days prior to enrolment. Additionally, subjects previously included into this study and whom then dropped out of the study is not to be re-entered into the study.
- •7. Subjects with any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug.
- •8. Subjects who are using drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone) within the previous 30 days (or 5 half lives of inducing agent, whichever is longer) of enrolment in this study.
- •9. Subjects with a medical history of seizures.
研究者
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