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
- Conditions
- Healthy smokers in a pharmacokinetic study for approved products
- Registration Number
- EUCTR2008-007238-23-SE
- Lead Sponsor
- iconovum AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To detemine bioequvalence between the two products.;Secondary Objective: To compare increase in plasma levels, effect on craving and time to effect.;Primary end point(s): Plasma levels of nicotine.
- Secondary Outcome Measures
Name Time Method