4 mg Nicotine Polacrilex Gum and Swedish Portion Snus

Phase 1

Completed

• Conditions: Healthy Subjects; Smokers
• Interventions: Drug: Nicotine

• Registration Number: NCT01182129
• Lead Sponsor: Contract Research Organization el AB

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2010-08
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Last Update Submitted: 2010-08-11
• Study First Posted: 2010-08-16
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy volunteer, smoking >7 cigarettes per day. No use of smokeless tobacco and nicotine containing products is allowed. Fasting overnight.

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Exclusion Criteria

• Use of smokeless tobacco and nicotine containing products is not allowed from 8 p.m. the day before trial day. Subjects tested with Smokelyzer for exhaled carbon monoxide.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Swedish Snus Type 2	Nicotine	The subject keeps one pouch of snus still between the upper lip and the gum for 30 minutes. Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax, AUCinf and heart rate for each treatment.
4 mg Nicorette chewing gum	Nicotine	Nicorette is chewed according to instructions in package insert over 30 minutes.
Swedish Snus Type 1	Nicotine	The subject keeps one pouch of snus still between the upper lip and the gum for 30 minutes. Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax, AUCinf and heart rate for each treatment.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic/Dynamic Equvivalence	8 hrs	After baseline measurements, plasma nicotine concentrations are monitored over 8 hours. Each subject's rating of subjective symptoms, e.g. product "strength" using a 100 mm visual analogue scale (VAS) anchored with "not at all" to "extremely" is recorded up to 30 minutes after dosing.

Trial Locations

Locations (1)

Carema AB; 🇸🇪 Eslov, Skane, Sweden