NCT01182129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

10 months

First QC Date

August 11, 2010

Last Update Submit

August 11, 2010

Conditions

Healthy SubjectsSmokers

Keywords

Nicotine Polacrilex chewing gum versus Swedish Snus

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic/Dynamic Equvivalence

    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.

    8 hrs

Study Arms (3)

Swedish Snus Type 1

ACTIVE COMPARATOR

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.

Drug: Nicotine

Swedish Snus Type 2

ACTIVE COMPARATOR

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.

Drug: Nicotine

4 mg Nicorette chewing gum

ACTIVE COMPARATOR

Nicorette is chewed according to instructions in package insert over 30 minutes.

Drug: Nicotine

Interventions

NicotineDRUG

Nicotine pouch, 2.2 mg, single dose, 30 minutes

Also known as: General Onyx 1 g portion snus, General White 1g portion snus
Swedish Snus Type 1Swedish Snus Type 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carema AB

Eslöv, Skåne County, 241 23, Sweden

Location

MeSH Terms

Interventions

NicotineNicotine Chewing GumChewing Gum

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Erik Lunell, MD, PhD

    Croel AB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 16, 2010

Study Start

March 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations

SE(1)