Smoking cessation
Conditions
Interventions
Product Name: Nicachet
Product Code: N07BA01
Pharmaceutical Form: Oral powder
Sponsors
Magle AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare each subject’s maximum plasma concentration of nicotine (Cmax) and (Tmax) of one single dose of 4 mg Nicachet nicotine oromucosal powder in pouch to that of one piece of 4 mg Nicorette® chewing gum and 1mg (two sprayings of 0.5 mg) Nicorette® nasal spray, respectively (hybrid application).;Secondary Objective: From the nicotine plasma concentration-time curves the plasma concentration of nicotine at 30 minutes after administration (C30min), AUC6h, AUCinf, and T1/2 will be calculated. Secondary objective is to compare these variables, for Nicachet 4mg nicotine oromucosal powder in pouch to the 4mg Nicorette® chewing gum and 1mg Nicorette® nasal spray. To compare each subject’s rating of subjective effects using a Visual Analogue Scale (VAS) anchored with "not at all" to "extremely" at the time points of blood sampling. ;Primary end point(s): To compare each subject’s maximum plasma concentration of nicotine (Cmax) and (Tmax) of one single dose of 4 mg Nicachet nicotine oromucosal powder in pouch to that of one piece of 4 mg Nicorette® chewing gum and 1mg (two sprayings of 0.5 mg) Nicorette® nasal spray. | — |
Countries
Sweden
Outcome results
None listed