4 mg Nicotine Polacrilex Gum and Swedish Portion Snus
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
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.