4 mg Nicotine Polacrilex Gum and Swedish Portion Snus (SMWS06)

This study has been completed.
Sponsor:
Collaborator:
Swedish Match AB
Information provided by:
Contract Research Organization el AB
ClinicalTrials.gov Identifier:
NCT01182129
First received: August 11, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Smokers
Drug: Nicotine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Nicotine Delivery and Subjective Effects of 4 mg Nicotine Polacrilex Chewing Gum Compared With Swedish Portion Snus

Resource links provided by NLM:


Further study details as provided by Contract Research Organization el AB:

Primary Outcome Measures:
  • Pharmacokinetic/Dynamic Equvivalence [ Time Frame: 8 hrs ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: March 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Swedish Snus Type 1
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
Nicotine pouch, 2.2 mg, single dose, 30 minutes
Other Names:
  • General Onyx 1 g portion snus
  • General White 1g portion snus
Active Comparator: Swedish Snus Type 2
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
Nicotine pouch, 2.2 mg, single dose, 30 minutes
Other Names:
  • General Onyx 1 g portion snus
  • General White 1g portion snus
Active Comparator: 4 mg Nicorette chewing gum
Nicorette is chewed according to instructions in package insert over 30 minutes.
Drug: Nicotine
Chewing Gum, 4 mg, single dose, 30 minutes
Other Name: Nicorette 4 mg chewing gum

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182129

Locations
Sweden
Carema AB
Eslov, Skane, Sweden, 241 23
Sponsors and Collaborators
Contract Research Organization el AB
Swedish Match AB
Investigators
Principal Investigator: Erik Lunell, MD, PhD Croel AB
  More Information

Additional Information:
No publications provided

Responsible Party: Erik Lunell, MD, PhD, CROel AB, Slottsvagen 21, SE25284 Helsingborg, Sweden
ClinicalTrials.gov Identifier: NCT01182129     History of Changes
Other Study ID Numbers: SMWS06
Study First Received: August 11, 2010
Last Updated: August 11, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Contract Research Organization el AB:
Nicotine Polacrilex chewing gum versus Swedish Snus

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014