Tobacco dependence
Conditions
Sponsors
Pfizer Health AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female subjects between the ages of 18 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests, as judged by the investigator. Smoking of at least 15 cigarettes daily during at least one year preceding inclusion and no intention to quit within three months from inclusion. For females: Postmenopausal state with absence of menstrual discharge for at least two years and a serum FSH level >30 IU/L or premenopausal/perimenopausal state with effective contraception (oral or implanted hormonal contraceptives, intrauterine device or status after operative sterilization). Body Mass Index (BMI) of 17.5 to 30.0 kg/m2; and a total body weight 50.0 kg. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in this protocol. 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
Exclusion criteria
Exclusion criteria: Evidence or history of a severe acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or use of drugs, that, in the judgment of the investigator, increase the risk associated with study participation or interfere with the interpretability of study results. Females: Premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria. History of regular alcohol consumption in the 6 months before screening. Weekly limits are 2 L of wine or 5 L of beer or 0.6 L of spirits for females and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages. Treatment with an investigational drug within 3 months preceding the first dose of trial medication. Donation or loss of blood within 3 months prior to dosing, if the estimated lost blood volume equaled or exceeded 450 mL. History of sensitivity to heparin or heparin-induced thrombocytopenia. A pathological dental status interfering with normal chewing function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate and to compare the pharmacokinetics of nicotine after administration of nicotine pullulan film at doses of 2 and 3 mg, respectively, of nicotine metolose film at a dose of 2 mg, and of Nicorette® gum 2 mg.;Secondary Objective: to estimate the mean dose of the nicotine pullulan film that results in an AUC8 equivalent to that of Nicorette® gum 2 mg, to assess irritation in mouth and throat associated with study treatments, to assess the general acceptance of study treatments, to assess urges to smoke at specified times during study treatments, to assess the amount of nicotine extracted from the Nicorette® gum during 30 minutes of chewing, to assess tolerability and safety of study treatments. ;Primary end point(s): The primary study endpoints are nicotine AUC8, Cmax and AUCt. | — |
Countries
Sweden
Outcome results
None listed