Healthy smokers in a pharmacokinetic study for approved products
Conditions
Interventions
Trade Name: Zonnic Mint 1,5 mg, medicated chewing gum
Product Name: Zonnic 1,5 mg medicated chewing-gum
Pharmaceutical Form: Medicated chewing-gum
INN or Proposed INN: nicotine
CAS Number: 54115
Other
Sponsors
Niconovum AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed