Healthy Subjects Clinical Trial
Official title:
Nicotine Delivery and Subjective Effects of 4 mg Nicotine Polacrilex Chewing Gum Compared With Swedish Portion Snus
Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8 hours after administration for determination of nicotine. Mean + SD extracted dose of nicotine from each preparation will be estimated. The percentage extracted of the nicotine content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in relation to the dose following the 4 mg Nicorette chewing gum will be calculated. Self-reports of subjective effects will be obtained up to 30 minutes after the test product is administered using a 100 mm visual analogue scale (VAS) anchored with "not at all" to "extremely". Study hypothesis is that Cmax and AUC of Nicorette 4 mg chewing gum and Swedish snus are similar.
Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General
White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial
blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8
hours after administration for determination of nicotine. Mean + SD extracted dose of
nicotine from each preparation will be estimated. The percentage extracted of the nicotine
content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg
chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in
relation to the dose following the 4 mg Nicorette chewing gum will be calculated.
Self-reports of subjective effects will be obtained up to 30 minutes after the test product
is administered using a 100 mm visual analogue scale (VAS) anchored with "not at all" to
"extremely".
The subjects are male and female smokers, smoking a minimum of 7 cigarettes per day. They
should have no history of cardiac, kidney or hepatic disease, alcohol abuse or drug
dependence. A physical examination including ECG and blood pressure should give no evidence
of disease. No abnormalities should be found in a routine laboratory screening.
The subjects are requested not to smoke or to use any other form of nicotine containing
products from 8 p.m. the day before each session until the last blood sample in each
session. Previous experience has shown that subjects that have abstained from smoking for 12
hours have a plasma nicotine value of <4 ng/ml. A value >4 ng/ml prior to start of
administration should lead to exclusion from statistical analysis. The subjects must be
fasting overnight from 12 p.m. the day before each session. No food and drink are allowed
from 15 minutes prior to and until 60 minutes after drug administration.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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