跳至主要内容
临床试验/EUCTR2008-007238-23-SE
EUCTR2008-007238-23-SE进行中(未招募)不适用

Anopen label, randomised, two-way crossover bioequivalence study in healthy sokers of Zonnic 1,5 mg nicotine gum versus Nicorette 4 mg nicotine chewing gum Classic flavour

iconovum AB0 个研究点开始时间: 2008年12月17日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Consent to participate voluntarily and sign Informed Consent prior to any study procedure. Healthy male and female, aged 18-60 years. Willing and able to chew nicotine gum. Smoker of at least 10 cigarettes per 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)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Subjects who are participating in other drug studies or who have received other investigational drugs within 30 days prior to enrolment. Subjects with any surgical or medical condition, which, in the judgement of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug. Subjects who are using drugs capable of inducing hepatic enzyme metabolism (e g barbiturates, rifampicin, carbamazeoine, phenytoin, primidone) within the previous 30 days (or 5 half-lives of inducing agent whichever is longer) of enrolment in this study.

研究者

发起方
iconovum AB

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