Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01084707
First received: March 9, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.


Condition Intervention
Tobacco Dependence
Drug: Oral Nicotine
Drug: Nicotine Lozenge
Drug: Nicotine gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Maximum Plasma Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]
    Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

  • Average Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]
    Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)


Secondary Outcome Measures:
  • Time of Maximum Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]
    The time at which maximum concentration is reached (Tmax)

  • Minimum Plasma Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]
    The minimum nicotine plasma concentration during the last dosing interval (Cmin)

  • Peak-Trough Fluctuation [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]
    Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)

  • Nicotine Plasma Concentration [ Time Frame: One hour after start of treatment ] [ Designated as safety issue: No ]
    The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Nicotine 24-SA
2 Self-administrations of Experimental Nicotine once every hour
Drug: Oral Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Other Name: generic Nicotine
Experimental: Oral Nicotine 24
2 administrations of Experimental Nicotine by study personnel once every hour
Drug: Oral Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Other Name: generic Nicotine
Experimental: Oral Nicotine 48
2 administrations of Experimental Nicotine by study personnel once every 30 minutes
Drug: Oral Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Other Name: generic Nicotine
Active Comparator: NiQuitin™ Lozenge 4 mg
1 NiQuitin™ lozenge, administered by study personnel once every hour
Drug: Nicotine Lozenge
Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours
Other Name: NiQuitin™
Active Comparator: Nicorette® Gum 4 mg
1 piece Nicorette® gum, chewed for 30 minutes once every hour
Drug: Nicotine gum
Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours
Other Name: Nicorette®

Detailed Description:

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
  • Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
  • A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Pregnancy, lactation or intended pregnancy.
  • Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
  • Prior regular use of nicotine mouth spray
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084707

Locations
Sweden
Clinical Pharmacology
Lund, Sweden, 222 20
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01084707     History of Changes
Other Study ID Numbers: NICTDP1066-A6431117, 2008-006279-65
Study First Received: March 9, 2010
Results First Received: April 16, 2010
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation, Nicotine pharmacokinetics

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014