Status:
COMPLETED
Sublingual Nicotine Tablets Compared With Swedish Snus
Lead Sponsor:
Contract Research Organization el AB
Collaborating Sponsors:
Commitum AB
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 ni...
Detailed Description
Open, randomized, five-way cross-over. Single dose administration. The Nicorette 6 mg sublingual tablets and three strengths of SS are tested. Subjects are 18-50 years old, male/female (non-pregnant),...
Eligibility Criteria
Inclusion
- Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure.
- Healthy male/female, age 18 through 50 years. Female using contraceptive pill or negative pregnancy test.
- Willing and able to comply with study procedures.
- Snus user, minimum 12 pouches or half a can of loose snus per day of pouched portion snus, minimum 1 gram/portion.
- Abstinent from any form of nicotine use from 8.00 p.m.
- Fasting overnight from 11.00 p.m.
Exclusion
- Smoker, defined as "smoking during the last 24 hours according to self report and CO in exhaled air \>10 ppm at clinical visits"
- 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.
- 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.
- 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.
- 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.
- Subjects who have participated in other drug studies within 30 days prior to enrolment.
- 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.
- 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.
- Subjects with a medical history of seizures.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01838460
Start Date
May 1 2012
End Date
February 1 2013
Last Update
April 24 2013
Active Locations (1)
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1
Carema Specialistvård, Eslöv
Eslöv, Skåne County, Sweden, 24123