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4 mg Nicotine Polacrilex Gum and Swedish Portion Snus

NCT01182129 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2010-08-16

No results posted yet for this study

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.

Conditions

  • Healthy Subjects
  • Smokers

Interventions

DRUG

Nicotine

Nicotine pouch, 2.2 mg, single dose, 30 minutes

DRUG

Nicotine

Chewing Gum, 4 mg, single dose, 30 minutes

Sponsors & Collaborators

  • Swedish Match AB

    collaborator INDUSTRY

  • Contract Research Organization el AB

    lead INDUSTRY

Principal Investigators

  • Erik Lunell, MD, PhD · Croel AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01182129 on ClinicalTrials.gov