Sublingual Nicotine Tablets Compared With Swedish Snus

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Contract Research Organization el AB
• Collaborator: Commitum AB
• Treatments: Lobeline; Nicotine

Criteria

Inclusion Criteria:

1. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure.

2. Healthy male/female, age 18 through 50 years. Female using contraceptive pill or negative pregnancy test.

3. Willing and able to comply with study procedures.

4. Snus user, minimum 12 pouches or half a can of loose snus per day of pouched portion snus, minimum 1 gram/portion.

5. Abstinent from any form of nicotine use from 8.00 p.m.

6. Fasting overnight from 11.00 p.m.

Exclusion Criteria:

1. Smoker, defined as "smoking during the last 24 hours according to self report and CO in exhaled air >10 ppm at clinical visits"

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 males or > 470 msec for females); other clinically significant heart conditions which would negatively impact on the subject completing the study.

3. Subjects with clinically significant liver disease which may prevent the subject 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 subject 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 subject's participation in the clinical study.

6. Subjects who have participated in other drug studies within 30 days prior to enrolment.

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 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.